S M I T H & N E P H E W O R T H O P A E D I C S

THE SMITH & NEPHEW

HUMERAL INTERLOCKING NAIL
S U R G I C A L T E C H N I Q U E
THE SMITH & NEPHEW
HUMERAL INTERLOCKING NAIL
by
Da vid G. La Velle, M.D., Th om a s A. Ru ssell, M.D.,
a n d Joh n Ch a r les Ta ylor, M.D., Mem ph is, Ten n essee;
Ja m es N. Powell, M.D., Tor on to, On ta r io;
a n d Kevin Ch r istia n sen , M.D., Hon olu lu , Ha wa ii
TA B L E OF CON T E N T S
I n tr odu ction ................................................................ 3
Design Fea tu r es .......................................................... 4
Su r gica l Tech n iqu e 1 An tegr a de ............................ 5
Su r gica l Tech n iqu e 2 Retr ogr a de .......................... 15
Ca ta log I n for m a tion ................................................... 25
Nota Bene: Th e tech n iqu e descr iption h er ein is m a de
a va ila ble to th e h ea lth ca r e pr ofession a l to illu str a te th e
a u th or s su ggested tr ea tm en t for th e u n com plica ted
pr ocedu r e. I n th e fin a l a n a lysis, th e pr efer r ed tr ea tm en t is
th a t wh ich a ddr esses th e n eeds of th e specific pa tien t.
I N T R ODU CT I ON
3
h e Sm ith & Neph ew I n ter lockin g
Na il System wa s design ed with two
over a ll goa ls for th e h ea lin g of lon g
bon e fr a ctu r es. Th e fir st wa s to im pr ove
th e clin ica l su ccess of pr eviou sly a va ila ble
in ter lockin g n a ils by r edu cin g com plica -
tion s. Th e secon d over a ll goa l wa s to
design a n in ter lockin g n a il system th a t
wou ld be m or e a ccepta ble for tr ea tin g
com plex fr a ctu r es of th e fem u r ( in clu din g
ipsila ter a l n eck/ sh a ft, su btr och a n ter ic,
a n d pa th ologic fr a ctu r es) a s well a s com -
plex fr a ctu r es of th e tibia a n d h u m er u s.
Th e pr im a r y fea tu r e of th e I n ter lockin g
Na il is th e n on - slotted or closed section
design . Th is is differ en t fr om th e fir st
widely a ccepted design for a n I M n a il
wh ich con ta in ed a lon gitu din a l slot begin -
n in g a t th e dista l en d a n d pr oceedin g
pr oxim a lly eith er th e fu ll len gth of th e
n a il or to with in a few cen tim eter s of th e
pr oxim a l en d.
Th e closed section design of th e
I n ter lockin g Na il over com es th e biom e-
ch a n ica l sh or tcom in gs of a slotted n a il
a n d, th er efor e, in h er en tly a n swer s som e
of th e over a ll design goa ls. Th e elim in a -
tion of th e slot r edu ces com plica tion s by:
1. Decr ea sin g tor sion a l sh ea r post-
oper a tively in th e h ea lin g bon e,
2. I n cr ea sin g th e a m ou n t of m a ter ia l
a r ou n d th e scr ew h oles,
3. Redu cin g tor sion a l r ota tion du r in g
in ser tion of th e n a il, a n d,
4. Ea sin g dista l ta r getin g.
An oth er equ a lly im por ta n t a r ea in th e
design of th e in ter lockin g n a il con cer n ed
th e ben din g str en gth . Th is wa s especia lly
cr itica l in ligh t of th e secon d over a ll
design goa l of th e I n ter lockin g Na il
System : for th e in ter lockin g n a il to be
m or e a ccepta ble for tr ea tin g com plex
fr a ctu r es of th e fem u r ( in clu din g ipsila t-
er a l n eck/ sh a ft, su btr och a n ter ic a n d
pa th ologic fr a ctu r es) , a s well a s com plex
fr a ctu r es of th e tibia a n d h u m er u s. I t wa s
felt th a t sm a ller n a ils cou ld be ver y u sefu l
in th e tr ea tm en t of open fr a ctu r es a n d in
tr ea tin g sm a ll bon ed pa tien ts. However,
befor e th is cou ld becom e a r ea lity,
u n r ea m ed in ter lockin g n a ils wou ld
h a ve to be str on ger th a n th eir h istor ica l
cou n ter pa r ts wh ich wer e r epor ted to h a ve
h igh er br ea ka ge r a tes in n a ils of less th a n
13 m m in dia m eter.
1,2,3
Th e pr a ctica l m a n ifesta tion of th e a tten -
tion to str en gth r equ ir em en ts ca n be seen
in th e I n ter lockin g DELTA

n a ils a n d th e
DELTAI I n a ils. Th ese n a ils h a ve in cr ea sed
wa ll th ickn ess in sm a ller dia m eter s in
or der to m a in ta in str en gth wh ile a voidin g
th e clin ica l pr oblem s of a n over ly stiff
n a il. Clin ica lly, th ese sm a ller dia m eter
in ter lockin g n a ils h a ve been ver y effective
in th e tr ea tm en t of open fr a ctu r es wh er e
th ey cou ld be u sed with ou t r ea m in g. Th ey
h a ve a lso been u sed a s th e n a il of ch oice
in pa tien ts with sm a ll ca n a ls th a t cou ld
n ot h a ve ea sily with stood th e excessive
a m ou n t of r ea m in g n ecessa r y to in ser t a
sta n da r d dia m eter in tr a m edu lla r y n a il.
REFERENCES
1
Kyle, R. F.; a n d La tta , L. L.: Mech a n ics of Fem or a l
I n tr a m edu lla r y Na ilin g, AAOS Com m ittee of
Biom ech a n ica l En gin eer in g, La s Vega s, 1985.
2
Fr a n klin , J. L.; Win qu ist, R. A.; Ben ir sch ke, S. K.; a n d
Ha n sen , S. T. Jr.: Br oken I n tr a m edu lla r y Na ils, J. Bon e
a n d Join t Su r g., 70- A: 1463- 1471, 1988.
3
Bu ch olz, R. W.: Dilem m a s a n d Con tr over sies in
I n tr a m edu lla r y Na ilin g in Th e Scien ce a n d Pr a ctice of
I n tr a m edu lla r y Na ilin g. Ed by Br own er, Br u ce D. a n d
Edwa r ds, Ch a r les C., Lea a n d Febiger, 1987,
Ph ila delph ia , pg. 85- 89.
T
DE S I GN F E AT U R E S
4
h e Ru ssell-Ta ylor

( R-T)
Hu m era l Na il is a va ila ble in
sh a ft dia m eters of 7, 8, a n d
9 m m . Th e proxim a l en d is ta pered to
9 m m . Th e 8 a n d 9 m m n a ils a re
ca n n u la ted a n d ca n be in serted over a
2.4 m m Gu ide Rod. Th e 7 m m n a il is
solid. Proxim a lly a n d dista lly, th e R-T
Hu m era l Na il u ses 4.0 m m fu lly
th rea ded, self-ta ppin g bon e screws.
Th ey a llow for bi-cortica l fixa tion to
redu ce th e possibility of screw ba ckou t,
a n d ca n be u sed to h elp m a in ta in
len gth a n d preven t rota tion . Th e R-T
Hu m era l Na il h a s a u n iqu e Proxim a l
Drill Gu ide wh ich a llows 20
0
va ria n ce
for proxim a l screw in sertion . Design ed
to a ddress th e widen in g spectru m of
in dica tion s for fra ctu res of th e
h u m eru s, th e R-T Hu m era l Na il a llows
for in tra m edu lla ry fixa tion of h u m era l
sh a ft fra ctu res, in clu din g th ose th a t a re
segm en ta l or severely com m in u ted. It is
u sefu l for th e trea tm en t of fra ctu res,
n on u n ion s, a n d pa th ologic fra ctu res of
th e h u m era l sh a ft, from 3 cm su perior
to th e olecra n on fossa , to with in 2 cm
of th e su rgica l n eck of th e h u m eru s.
Th e R-T Hu m era l Na il is design ed for
rea m ed or n on -rea m ed a pplica tion a n d
ca n be in serted a n tegra de or retrogra de.
T
THE R-T HUMERAL
INTERLOCKING NAIL
9 mmproximal end.
The7 mmnail is solid,
and the8 and 9 mm
nails arecannulated and
can beinserted over a
2.4 mmguiderod.
Closed section design
for torsional stability.
7, 8, and 9 mm
diameters
areavailable.
Proximal and distal
interlockingwith
4.0 mmfully
threaded screws.
Positivelock keyway
provides secureinstru-
ment fit for accurate
proximal targeting.
Uniqueproximal drill
guideallows 20
O
variancefor proximal
screw placement.
S U R G I C A L T E C H N I Q U E A N T E G R A D E
5
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PREOPERATI VE PLANNI NG
reopera tive ra diogra ph s of th e
u n in ju red h u m eru s m a y be u sed to
estim a te proper n a il dia m eter,
expected a m ou n t of rea m in g ( if n ecessa ry) ,
a n d fin a l n a il len gth for severely com m in -
u ted fra ctu res. ( X-ra y tem pla tes for th e R-T
Hu m era l Na il a re a va ila ble for preopera tive
pla n n in g.)
Proper len gth a n d a lign m en t m u st be
obta in ed with tra ction before in itia tin g
closed a n tegra de in tra m edu lla ry n a ilin g. In
la te displa ced fra ctu res, open redu ction
m a y be requ ired to preven t bra ch ia l plexu s
pa lsies. Idea lly, th e n a il selected wou ld be
in serted ju st m edia l to th e tip of th e grea ter
tu berosity, a pproxim a tely a h a lf cen tim eter
posterior to th e bicipita l groove ( to m in i-
m ize da m a ge to th e rota tor cu ff) , a n d
sh ou ld be tem pla ted to be bu ried in th e
bon e proxim a lly, to m in im ize su ba crom ia l
im pin gem en t. It is im porta n t th a t th e en try
porta l be in lin e with th e m idpla n e of th e
h u m eru s. Th e n a il len gth a n d dia m eter
sh ou ld ta ke in to a ccou n t th e dista l n a rrow-
in g of th e h u m eru s. Th e n a il sh ou ld en d
a pproxim a tely 1-2 cm proxim a l to th e ole-
cra n on fossa . In com m in u ted fra ctu res,
ca re sh ou ld be ta ken th a t th e h u m eru s is
n ot len gth en ed, a s th is m a y lea d to dela yed
h ea lin g. Du e to th e circu la r cross section of
th e h u m eru s in th e proxim a l two-th irds
a n d th e n a rrowin g a n d fla tten in g of th e
m edu lla ry ca n a l dista lly, it is difficu lt to
obta in tru e in terferen ce fit. Th erefore, sta tic
in terlockin g sh ou ld be stron gly con sidered
in th e trea tm en t of th ese fra ctu res.
Th e n a il size u sed depen ds on th e size of
th e pa tien t a n d th e exten t of h u m era l com -
m in u tion . It sh ou ld be n oted, h owever, th a t
a sm a ll bu t con sisten t percen ta ge of com -
plica tion s du e to n a il fa tigu e fa ilu re
rem a in . Th erefore, it is a lwa ys recom -
m en ded th a t th e la rgest im pla n t su ita ble
for th e pa tien t be u sed.
NOTE: Intr amedullar y nails ar e not
intended to car r y significant loads for
extended per iods of time. All patients
should be cautioned against significant
weight bear ing such as walking with the
use of cr utches, canes, or walker s pr ior
to good callus for mation. Lifting heavy
weights beyond knee level and excessive
r otation of the elbow should also be
avoided. For this r eason, patients who
ar e noncompliant, as well as patients
who could be pr edisposed to delayed or
nonunions, must have exter nal suppor t.
P
Fractures situated in theshaded area can
betreated with an R-T Humeral Nail.
6
S U R GI CA L T E CH N I QU E A N T E GR A DE
PATI ENT POSI TI ONI NG
In th e su pin e position , tu rn th e pa tien t' s
h ea d to th e con tra la tera l side to m a xim ize
exposu re of th e sh ou lder. Tra ction m a y be
a pplied th rou gh a skeleta l tra ction pin in
th e olecra n on a tta ch ed to a tra ction bow.
Obta in rota tion a l a lign m en t by pla cin g th e
sh ou lder in a n a n a tom ic position a n d
rota tin g th e dista l fra gm en t su ch th a t th e
a rm a n d h a n d a re poin tin g towa rd th e ceil-
in g with th e elbow flexed 90
O
(Figure1).
Opera tin g on a ra diolu cen t ta ble top will
a id in ra diogra ph ic im a gin g du rin g th e
ca se.
PATI ENT PREPARATI ON
Scru b a n d prepa re th e pa tien t to in clu de
th e proxim a l sh ou lder proxim a lly to th e
lin e of th e n ipple, m idlin e of th e ch est to
th e n a pe of th e n eck, a n d th e en tire extrem -
ity to th e fin gers. Sterile towels su tu red or
clipped to th e skin will preven t th eir m ove-
m en t in th e a rea of th e a xilla . Cover th e
im a ge in ten sifier a rm with a sterile isola -
tion dra pe.
SURGI CAL TECHNI QUE
Ma ke a lon gitu din a l skin in cision from th e
m ost la tera l poin t of th e a crom ion . Exten d
it dista lly, cen tered over th e tip of th e
grea ter tu berosity. In cise th e fa scia of th e
deltoid a n d pa lpa te th e grea ter tu berosity.
Ta ke ca re n ot to exten d th e in cision m ore
th a n 4-5 cm in th e deltoid m u scle to a void
da m a ge to th e a xilla ry n erve.
Figure1
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S U R GI CA L T E CH N I QU E A N T E GR A DE
7
21-6600
11-5120
HUMERAL PREPARATI ON
Usin g th e Cu rved Awl, esta blish th e en try
porta l site ju st m edia l to th e tip of th e
grea ter tu berosity a n d con firm th is with
im a ge in ten sifica tion (Figure2). Adva n ce
th e Cu rved Awl u n til it is sea ted with in th e
h u m era l h ea d a n d rota te th e h u m eru s
in tern a lly a n d extern a lly to con firm con -
ta in m en t of th e Cu rved Awl by im a ge in ten -
sifica tion . Th e en try porta l sh ou ld be cen -
tered on both views su ch th a t th e n a il will
be in th e m idpla te of th e h u m eru s.
GUI DE ROD I NSERTI ON
With dra w th e Cu rved Awl a n d in sert th e
2.0 m m Ba ll Tipped Rea m er Gu ide Rod
(Figure3). Ben din g th e tip of th e Gu ide
Rod m a y a id in redu ction . Adva n ce it down
th e m edu lla ry ca n a l. By in tern a lly a n d
extern a lly rota tin g th e a rm , im a ge in ten si-
fica tion will con firm con ta in m en t of th e
Gu ide Rod. Adva n ce th e Gu ide Rod in to th e
cen ter of th e dista l fra gm en t u n til th e tip is
1-2 cm proxim a l to th e olecra n on fossa .
Con ta in m en t of th e gu ide rod dista lly is
con firm ed by in tern a l a n d extern a l rota tion
of th e h u m eru s wh ile a voidin g distra ction
a n d sh orten in g.
HUMERAL NAI L LENGTH
DETERMI NATI ON
Verifica tion of th e proper n a il len gth m a y
be determ in ed by two sepa ra te m eth ods:
Guide Rod Method With th e dista l en d
of th e Gu ide Rod 1-2 cm proxim a l to th e
olecra n on fossa , overla p a secon d Gu ide
Rod exten din g proxim a lly from th e
h u m era l en try porta l. Su btra ct th e len gth
Figure 2
Figure 3
S U R GI CA L T E CH N I QU E A N T E GR A DE
8
( X m m ) of th e overla pped Gu ide Rod from
700 m m to determ in e n a il len gth (Figure4).
Nail Length Gauge Position th e Na il
Len gth Ga u ge a n terior to th e h u m eru s
( u n a ffected h u m eru s preopera tively; a ffected
h u m eru s in tra opera tively) , with its dista l
en d 1-2 cm proxim a l to th e olecra n on fossa .
Move th e C-a rm to th e proxim a l en d of th e
h u m eru s a n d u se th e im a ge in ten sifier to
rea d th e correct n a il len gth directly from th e
sta m pled m ea su rem en ts on th e Na il Len gth
Ga u ge (Figure5).
REAMED TECHNI QUE
For a rea m ed tech n iqu e, rea m th e en tire
h u m eru s over th e 2.0 m m Ba ll Tipped
Rea m er Gu ide Rod in 0.5 m m in crem en ts,
u n til th e desired dia m eter is a ch ieved
(Figure6). Gen tly rea m th e dista l en d
1-2 cm proxim a l to th e olecra n on fossa .
Exercise ca u tion , a s th e cortica l th ickn ess of
th e h u m eru s is m u ch less th a n th a t of th e
tibia a n d fem u r a n d th e procedu re is often
perform ed in osteoporotic bon e. If th e en try
porta l is too la tera l, th e la tera l wa ll of th e
proxim a l h u m eru s m a y be rea m ed ou t or
fra ctu red du rin g n a il in sertion . Pu sh in g th e
rea m er sh a ft m edia lly m a y preven t th is
com plica tion . Th e fin a l rea m er dia m eter
sh ou ld be verified with th e Rea m er
Tem pla te. It is essen tia l to rea m 0.5-1 m m
over th e selected n a il dia m eter. Never inser t
a nail that has a lar ger diameter than the
last r eamer used.
Use th e Medu lla ry Exch a n ge Tu be over th e
2.0 m m Ba ll Tipped Rea m er Gu ide Rod to
m a in ta in fra ctu re redu ction . Repla ce th e
2.0 m m Ba ll Tipped Rea m er Gu ide Rod with
a 2.4 m m Na il Gu ide Rod. Rem ove th e
Medu lla ry Exch a n ge Tu be.
11-2023
11-2058
11-5115
11-5123
Figure 4
Figure 5
Figure 6
700 mm X =
Nail Length
X

m
m
S U R GI CA L T E CH N I QU E A N T E GR A DE
9
11-8190
11-8192
11-8194
11-8196
11-8198
11-8200
11-0566
11-5125
11-5113
11-5116
UNREAMED TECHNI QUE
For th e u n rea m ed tech n iqu e, In terch a n ge-
a ble Sou n ds ca n be u sed to determ in e th e
dia m eter of th e ca n a l a n d proper n a il size
prior to in sertion of th e n a il. In th is situ a -
tion , th e proxim a l m eta ph ysis of th e
h u m eru s sh ou ld be rea m ed to a dia m eter of
10 m m a pproxim a tely 4 cm in len gth to
open th e m edu lla ry ca n a l. Th e sou n ds a re
in serted over th e Gu ide Rod. Th e sou n ds
m u st be in serted m a n u a lly, NOT DRIVEN. If
resista n ce is en cou n tered, STOP, a n d with -
dra w th e sou n d. Th e la rgest dia m eter sou n d
th a t ca n pa ss ea sily th rou gh th e isth m u s is
th e correct dia m eter for th e n a il. Preopera tive
estim a tes of ca n a l dia m eter sh ou ld be
obta in ed a s con firm a tion of th e correct n a il
dia m eter.
NAI L I NSERTI ON
NOTE: The 7 mm Humer al Nail is not
cannulated, ther efor e, the Guide Rod
must be r emoved and the 7 mm nail
inser ted under r adiogr aphic contr ol,
without a Guide Rod. Atta ch th e selected
n a il to th e Proxim a l Drill Gu ide. Hold th e
Proxim a l Drill Gu ide with th e h a n dle
poin ted a wa y from th e pa tien t a n d th e proxi-
m a l cu rva tu re of th e n a il poin ted la tera lly.
Th e Hexa gon a l Bolt sh ou ld be tigh ten ed
on to th e n a il with th e 9/ 16" Wren ch . Th e
drill gu ide ba rrel is a tta ch ed to th e h u m era l
ou trigger with th e kn u rled kn ob. Atta ch th e
Hu m era l Na il Driver to th e h exa gon a l bolt
on th e proxim a l drill gu ide.
Usin g th e Proxim a l Drill Gu ide Assem bly to
con trol rota tion , in sert th e n a il. If a Gu ide
Rod is u sed, th e n a il sh ou ld be driven gen tly
over th e Gu ide Rod to th e fra ctu re site.
At th is poin t, fra ctu re redu ction sh ou ld be
con firm ed a n d th e n a il gen tly pa ssed a cross
th e fra ctu re site to a void com m in u tion
(Figure7). Rem ove th e Gu ide Rod a fter th e
n a il h a s en tered th e dista l fra gm en t. Adva n ce
th e n a il dista lly u n til it is 1-2 cm proxim a l to
th e olecra n on fossa (Figure8). Ta ke ca re to
Figure 7
Figure 8
GuideRod
Hexagonal Bolt
Nail
Humeral
Nail Driver
Proximal
Drill Guide
Knurled
Knob
Drill Guide
Barrel
a void splittin g th e dista l h u m eru s or
developin g a su pra con dyla r fra ctu re from
wedgin g th e tip of th e n a il too close to th e
olecra n on fossa . However, wh en th e n a il
rea ch es th e fra ctu re site, redu ction is
m a in ta in ed m a n u a lly a n d th e n a il is
a dva n ced gen tly a cross th e fra ctu re site a n d
con firm ed on A-P a n d la tera l views by
rota tin g th e a rm in tern a lly a n d extern a lly
u n til n a il con ta in m en t in th e dista l fra g-
m en t is con firm ed. Sea t th e n a il so th a t th e
proxim a l en d of th e n a il is ben ea th th e
bon e to a void su ba crom ia l im pin gem en t.
PROXI MAL I NTERLOCKI NG
Pr oximal and distal inter locking involves
the use of 4.0 mm locking scr ews,
2.7 mm Dr ill Bit, 8 mm Br own Dr ill
Sleeve, and 2.7 mm Gr een Dr ill Sleeve.
It is im porta n t, a t th is poin t, th a t th e a rm
be a ddu cted to preven t da m a gin g th e
bra ch ia l a rtery with th e drill. Th e Proxim a l
Drill Gu ide a llows a dju stm en t of th e in ter-
lockin g screw a n gle by 20
O
. Th is m a xim izes
th e su rgeon ' s a bility to en ga ge th e best cor-
tica l bon e on th e m edia l su rfa ce of th e
h u m era l m eta ph ysis. After th e correct a n gle
is selected, m a ke a sta b wou n d th rou gh th e
skin . In trodu ce th e 8 m m Brown Drill
Sleeve th rou gh th e ba rrel of th e Proxim a l
Drill Gu ide a n d pu sh it to bon e (Figure9).
In trodu ce th e h u m era l 2.7 m m Green Drill
Sleeve th rou gh th e 8 m m Brown Drill
Sleeve. Atta ch th e 2.7 m m Troca r to th e
T-Ha n dle Ja cob' s Ch u ck a n d u se it to dim -
ple th e cortex (Figure10). Use th e 2.7 m m
Drill Bit to drill from th e la tera l cortex in to
S U R GI CA L T E CH N I QU E A N T E GR A DE
10
11-5122
11-5121
Figure 9
Figure 10
11-5117
11-5118
11-0257
S U R GI CA L T E CH N I QU E A N T E GR A DE
11
th e m edia l cortex of th e h u m eru s. Use th e
im a ge in ten sifier to a void overpen etra tion
of th e m edia l h u m era l cortex. To con firm
screw len gth u sin g th e Hu m era l Direct
Mea su rem en t Ga u ge, slide th e ga u ge
a ga in st th e Drill Bit a n d down to th e Green
Drill Sleeve a n d rea d th e correct screw
len gth (Figure11). In sert th e selected
4.0 m m fu lly th rea ded Hu m era l Lockin g
Screw th rou gh th e 8 m m Brown Drill
Sleeve with th e DELTATibia l/ Hu m era l
Hexdriver (Figure12). In osteoporotic
bon e, it m a y be n ecessa ry to pu t a wa sh er
on th e screw to preven t it from bein g cou n -
tersu n k. Con firm a tion of th e in terlockin g
screw with in th e n a il is m a de by in trodu c-
in g th e 2.4 m m Gu ide Rod th rou gh th e
proxim a l en d of th e n a il.
DI STAL I NTERLOCKI NG
With a n a n terior -posterior orien ta tion of
th e ova l dista l screw h ole, m a ke eith er a n
a n terior or posterior in sertion porta l for dis-
ta l in terlockin g. Th e a n terior a pproa ch is
preferred, wh ich in volves a percu ta n eou s
in cision th rou gh th e biceps m u scle dista lly.
Adva n ce th e im a ge in ten sifier over th e dis-
ta l h u m eru s u n til th e ova l slot is viewed
(Figure13). Ma ke a 1 cm tra n sverse skin
in cision , cen tered over th e slot of th e n a il.
Use a h em osta t to sprea d th rou gh th e
biceps m u scle. Atta ch a 2.7 m m Troca r to
th e T-Ha n dle Ja cob' s Ch u ck a n d u se it to
loca lize th e sta rtin g porta l in th e freeh a n d
tech n iqu e. First in trodu ce th e tip of th e
2.7 m m Troca r percu ta n eou sly th rou gh th e
biceps m u scle to th e a n terior cortex a n d
loca te th e tip in th e slot, first from a la tera l
to m edia l pla n e, a n d th en from a proxim a l
to dista l pla n e. Ideally, the 4.0 mm lock-
ing scr ew will be placed distally in the
Figure 11
Figure 12
Figure 13
oval hole to allow axial compr ession
dur ing postoper ative car e. Rota te th e
2.7 m m Troca r u pwa rd u n til it is pa ra llel
with th e im a ge bea m . Gently ta p th e Troca r
in to th e a n terior cortex of th e h u m eru s.
Ta ke ca re to a void a su pra con dyla r fra ctu re
with th is step. Rem ove th e T-Ha n dle Ja cob' s
Ch u ck a n d con firm th e pla cem en t of th e
pin with in th e slot of th e n a il with im a ge
in ten sifica tion . With th is pilot h ole esta b-
lish ed, in sert th e 2.7 m m Green Drill Sleeve
in to th e 8.0 m m Ha n d-Held Drill Sleeve.
In sert th e 2.7 m m Drill Bit in to th e Green
Drill Sleeve a n d a dva n ce it th rou gh th e
a n terior a n d posterior cortices of th e
h u m eru s (Figure14). Rem ove th e drill
sleeves a n d con firm con ta in m en t of th e
2.7 m m Drill with in th e slot of th e Hu m era l
Na il with im a ge in ten sifica tion . Repla ce th e
Drill Sleeves. Usin g th e Hu m era l Direct
Mea su rem en t Ga u ge, slide th e Ga u ge
a ga in st th e drill bit a n d down to th e Green
Drill Sleeve a n d rea d th e correct screw
len gth (Figure15).
S U R GI CA L T E CH N I QU E A N T E GR A DE
12
11-5129
Figure 14
Figure 15
11-5118
11-5130
S U R GI CA L T E CH N I QU E A N T E GR A DE
13
11-5127
11-5126
11-5175
11-2096
In sert th e selected 4.0 m m fu lly th rea ded
h u m era l lockin g screw with th e DELTA
Tibia l/ Hu m era l Hexdriver (Figure16). In
osteoporotic bon e, it m a y be n ecessa ry to
pu t a wa sh er on th e screw to preven t it from
bein g cou n tersu n k. After com pletion of su c-
cessfu l dista l in terlockin g, th e h u m eru s
sh ou ld be visu a lized in fu ll len gth views,
A-P a n d la tera l, with im a ge in ten sifica tion
(Figure17). Rem ove th e Hu m era l Na il
Driver a n d Proxim a l Drill Gu ide. Irriga te
both proxim a l a n d dista l in cision s with
sa lin e. In sert a dra in th rou gh th e skin if
n ecessa ry a n d close th e wou n d in la yers.
POSTOPERATI VE
Postopera tively, th e pa tien t is pla ced in a
lon g-a rm posterior pla ster splin t a n d colla r
a n d cu ff. After two to th ree da ys, pa tien ts
a re pu t in a ca st bra ce if th ere is con cern of
sta bility. Active ra n ge of m otion exercises
ca n begin a t fou r to seven da ys.
EXTRACTI ON TECHNI QUE
HUMERAL NAI L
Extra ct th e R-T Hu m era l Na il by first a pply-
in g th e Extra ction Bolt to th e proxim a l en d
of th e n a il. Th en rem ove th e in terlockin g
screws th rou gh percu ta n eou s in cision s.
Fin a lly, a tta ch th e Driver/ Extra ctor tu be
a n d drive th e n a il ou t with th e slotted h a m -
m er (Figure18).
Figure 17
Figure 18
Figure 16
S U R G I C A L T E C H N I Q U E R E T R O G R A D E
15
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PREOPERATI VE PLANNI NG
Preopera tive ra diogra ph s of th e u n in ju red
h u m eru s m a y be u sed to estim a te proper
n a il dia m eter, expected a m ou n t of rea m in g
( if n ecessa ry) , a n d fin a l n a il len gth for
severely com m in u ted fra ctu res. ( X-ra y tem -
pla tes for th e R-T Hu m era l Na il a re a va il-
a ble for preopera tive pla n n in g.)
Proper len gth a n d a lign m en t m u st be
a tta in ed with tra ction before in itia tin g
closed retrogra de in tra m edu lla ry n a ilin g. If
fixed tra ction is u sed, it sh ou ld be in term it-
ten t to preven t bra ch ia l plexu s pa lsies.
Th e Retrogra de Hu m era l In terlockin g
Na ilin g Tech n iqu e m a y be u sed in pa tien ts
with proxim a l th ird or m id-sh a ft h u m era l
fra ctu res with ou t distu rbin g th e rota tor cu ff
or th e su ba crom ia l spa ce. Th e retrogra de
tech n iqu e is con tra in dica ted in pa tien ts
wh o h a ve fra ctu res in th e dista l th ird of th e
h u m eru s, or in pa tien ts wh ose bon e is
osteopen ic, wh ich wou ld m a ke dista l in ser-
tion difficu lt. Pa tien ts wh ose m edu lla ry
ca n a ls a re less th a n 10 m m in dia m eter
sh ou ld h a ve a n a n tegra de n a ilin g. In com -
m in u ted fra ctu res, ta ke ca re n ot to
len gth en th e h u m eru s wh ile lockin g proxi-
m a lly a n d dista lly.
Th e n a il size u sed depen ds on th e size of
th e pa tien t a n d th e exten t of h u m era l com -
m u n ition . It sh ou ld be n oted, h owever, th a t
a sm a ll bu t con sisten t percen ta ge of com -
plica tion s du e to n a il fa tigu e fa ilu re
rem a in . Th erefore, it is a lwa ys recom -
m en ded th a t th e la rgest im pla n t su ita ble
for th e pa tien t be u sed.
16
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S U R GI CA L T E CH N I QU E R E T R OGR A DE
NOTE: Intr amedullar y nails ar e not
intended to car r y significant loads for
extended per iods of time. All patients
should be cautioned against significant
weight bear ing such as walking with the
use of cr utches, canes, or walker s pr ior
to good callus for mation. Lifting heavy
weights beyond knee level and excessive
r otation of the elbow should also be
avoided. For this r eason, patients who
ar e noncompliant, as well as patients
who could be pr edisposed to delayed or
nonunions, must have exter nal suppor t.
PATI ENT POSI TI ONI NG
Th e pa tien t m a y be pla ced eith er pron e or
in th e la tera l decu bitu s position for th e
retrogra de n a ilin g. If th e pa tien t is pron e,
su pport th e fra ctu red extrem ity by a
ra diolu cen t a rm boa rd (Figure1). In th e
la tera l decu bitu s position , su spen d th e fra c-
tu red extrem ity, bu t ta ke ca re n ot to distra ct
th e fra ctu re site, a s th is cou ld lea d to n eu -
rova scu la r com prom ise. Su spen sion m a y
be a ided by a n olecra n on pin (Figure2).
PATI ENT PREPARATI ON
Scru b a n d prepa re th e pa tien t to in clu de
th e region of th e dista l cla vicle, th e
a crom ion , a n d th e m edia l sca pu la . Th e
scru b a n d prep sh ou ld in clu de a ll of th e
a rm , th e forea rm , a n d th e h a n d. Cover th e
im a ge in ten sifier a rm with a sterile isola -
tion dra pe.
Figure1
Figure2
S U R GI CA L T E CH N I QU E R E T R OGR A DE
SURGI CAL TECHNI QUE
Ma ke a lon gitu din a l skin in cision , begin -
n in g a t th e tip of th e olecra n on a n d exten d
it proxim a lly a bou t 6 cm . Con tin u e th e
in cision th rou gh th e triceps, splittin g it in
lin e with its fibers. Iden tify a n d expose th e
olecra n on fossa in th e posterior h u m eru s
a n d th e region ju st proxim a l to th e olecra -
n on fossa .
HUMERAL PREPARATI ON
Usin g a drill, open th e posterior h u m era l
cortex a bou t 2.5 cm proxim a l to th e
proxim a l-m ost exten t of th e olecra n on
fossa (Figure3). En la rge th is h ole with a
Cu rved Awl or a ron gu er to 10 m m wide
a n d 20 m m lon g.
GUI DE ROD I NSERTI ON
With dra w th e Cu rved Awl a n d in sert th e
2.0 m m Ba ll Tipped Rea m er Gu ide Rod.
Ben din g th e tip of th e Gu ide Rod m a y a id
in redu ction . Adva n ce it down th e
m edu lla ry ca n a l. Usin g im a ge visu a liza -
tion , redu ce th e fra ctu re a n d pa ss th e Gu ide
Rod a cross th e fra ctu re site. Con firm pres-
en ce of th e Gu ide Rod in th e proxim a l fra g-
m en t of th e h u m eru s by rota tin g th e im a ge
in ten sifier a n d th e a rm in tern a lly a n d
extern a lly. On ce th e Gu ide Rod h a s been
con firm ed to be loca ted in th e m edu lla ry
ca n a l of th e proxim a l fra gm en t, pa ss th e
Gu ide Rod in to th e h u m era l h ea d
(Figure4).
17
Figure 3
Figure 4
11-5120
21-6600
S U R GI CA L T E CH N I QU E R E T R OGR A DE
HUMERAL NAI L LENGTH
DETERMI NATI ON
Verifica tion of th e proper n a il len gth m a y
be determ in ed by two sepa ra te m eth ods.
Guide Rod Method With th e proxim a l
en d of th e Gu ide Rod in th e h u m era l h ea d,
overla p a secon d Gu ide Rod exten din g dis-
ta lly from th e h u m era l en try porta l.
Su bra ct th e len gth ( X m m ) of th e over-
la pped Gu ide Rod from 700 m m to deter-
m in e n a il len gth (Figure5).
Nail Length Gauge Position th e Na il
Len gth Ga u ge a n terior to th e h u m eru s
( u n a ffected h u m eru s preopera tively;
a ffected h u m eru s in tra opera tively) with its
proxim a l en d cen tered in th e h u m era l
h ea d. Move th e C-a rm to th e dista l en d of
th e h u m eru s a n d u se th e im a ge in ten sifier
to rea d th e correct n a il len gth directly from
th e sta m ped m ea su rem en ts on th e Na il
Len gth Ga u ge (Figure6).
REAMED TECHNI QUE
For a rea m ed tech n iqu e, rea m th e en tire
h u m eru s over th e 2.0 m m Ba ll Tipped
Rea m er Gu ide Rod in 0.5 m m in crem en ts
u n til th e desired dia m eter is a ch ieved
(Figure7). Th e en try porta l a n d 4 cm in to
th e ca n a l sh ou ld be rea m ed to a t lea st 11-
12 m m dia m eter, if a dequ a te bon e stock is
a va ila ble. Ta ke ca re n ot to pen etra te th e
a n terior cortex wh en first pa ssin g th e
rea m er in to th e en try porta l a n d th e m ed-
du lla ry ca n a l of th e dista l fra gm en t. Rea m
th e dia ph ysis of th e h u m eru s 0.5 to 1.0 m m
over th e selected n a il dia m eter. Never
inser t a nail that has a lar ger diameter
than the last r eamer used.
18
Figure 5
Figure 6
Figure 7
700 mm X =
Nail Length
11-2058
S U R GI CA L T E CH N I QU E R E T R OGR A DE
Use th e Medu lla ry Exch a n ge Tu be over th e
2.0 m m Ba ll Tipped Rea m er Gu ide Rod to
m a in ta in fra ctu re redu ction . Repla ce th e
2.0 m m Ba ll Tipped Rea m er Gu ide Rod
with a 2.4 m m Na il Gu ide Rod. Rem ove th e
Medu lla ry Exch a n ge Tu be.
UNREAMED TECHNI QUE
For th e u n rea m ed tech n iqu e,
In terch a n gea ble Sou n ds ca n be u sed to
determ in e th e dia m eter of th e ca n a l a n d
proper n a il size prior to in sertion of th e
n a il. In th is situ a tion , en la rge th e dista l
m eta ph ysis of th e h u m eru s to 10 m m to
open u p th e m edu lla ry ca n a l. Sou n ds
sh ou ld be u sed prim a rily in open fra ctu res.
Th ey a re in serted a t th e fra ctu re site ra th er
th a n th e en try porta l. Th e sou n ds a re
in serted over th e Gu ide Rod. Th e sou n ds
m u st be in serted m a n u a lly a n d NOT DRI-
VEN. If resista n ce is en cou n tered, STOP,
a n d with dra w th e sou n d. Th e la rgest dia m -
eter sou n d th a t ca n pa ss ea sily th rou gh th e
isth m u s is th e correct dia m eter for th e n a il.
NAI L I NSERTI ON
The 7 mm Humer al Nail is not cannu-
lated, ther efor e, the Guide Rod must be
r emoved and the 7 mm nail should be
inser ted under r adiogr aphic contr ol
without a Guide Rod. Extrem e ca u tion
m u st be exercised wh en in sertin g th e n a il,
a s propa ga tion of th e en try porta l proxi-
m a lly, or drivin g th e n a il ou t th rou gh th e
a n terior cortex of th e h u m eru s is possible,
pa rticu la rly in osteopen ic bon e. If n eces-
sa ry, with dra w th e n a il a n d rea m th e en try
porta l a n d dista l ca n a l 1 or 2 m m m ore, if
a dequ a te bon e stock is a va ila ble.
19
11-5115
11-5123
11-8190
11-8192
11-8194
11-8196
11-8198
11-8200
S U R GI CA L T E CH N I QU E R E T R OGR A DE
Atta ch th e n a il to th e Proxim a l Drill Gu ide.
Th e Proxim a l Bolt sh ou ld be tigh ten ed
on to th e n a il with th e 9/ 16" Wren ch . Atta ch
th e Hu m era l Na il Driver to th e proxim a l
bolt. Usin g th e ou trigger to con trol rota tion ,
in sert th e n a il (Figure8). If a Gu ide Rod is
u sed, gen tly drive th e n a il over th e Gu ide
Rod to th e fra ctu re site (Figure9). At th a t
poin t, con firm fra ctu re redu ction a n d gen -
tly pa ss th e n a il a cross th e fra ctu re site to
a void com m in u tion . Rem ove th e Gu ide
Rod a fter th e n a il h a s crossed in to th e prox-
im a l fra gm en t. Con firm con ta in m en t of
th e n a il with in th e proxim a l fra gm en t by
rota tin g th e a rm a n d th e im a ge bea m .
Drive th e n a il u n til its cu rve, wh ich is fa c-
in g a n teriorly, is bu ried in th e m edu lla ry
ca n a l of th e h u m eru s. Th e dista l en d of th e
n a il sh ou ld be prom in en t n o m ore th a n
1 cm ou tside of th e m edu lla ry ca n a l. Th e
proxim a l en d of th e n a il sh ou ld en d n o
closer th a n 2 cm to th e su bch on dra l bon e,
a s closer pla cem en t wou ld pla ce th e proxi-
m a l in terlockin g screw in a position wh ere
it m a y im pin ge in th e su ba crom ia l spa ce.
DI STAL I NTERLOCKI NG
Th e R-T Hu m era l Na il is design ed so th a t,
with th e retrogra de tech n iqu e, th e dista l
screw is in serted from posterior to a n terior
a n d th e proxim a l screw is in serted from la t-
era l to m edia l. Th e dista l screw is pla ced
u sin g direct vision of th e bon e (Figure10).
In trodu ce th e 8.0 m m Brown Drill Sleeve
a n d th e 2.7 m m Green Drill Sleeve th rou gh
th e ba rrel of th e Proxim a l Drill Gu ide a n d
20
Figure 8
Figure 9
11-0566
11-5113
11-5116
11-5125
11-5122
Figure 10
11-5121
S U R GI CA L T E CH N I QU E R E T R OGR A DE
pu sh it to bon e. Atta ch th e 2.7 m m Troca r
to th e T-Ha n dle Ja cobs Ch u ck a n d u se it to
dim ple th e cortex. Use th e 2.7 m m Drill Bit
to drill from th e posterior cortex in to th e
a n terior cortex of th e h u m eru s (Figure
11). Use th e im a ge in ten sifier to a void
overpen etra tion of th e a n terior h u m era l
cortex. To con firm screw len gth u sin g th e
Hu m era l Direct Mea su rem en t Ga u ge, slide
th e ga u ge a ga in st th e Drill Bit a n d down to
th e Green Drill Sleeve a n d rea d th e correct
screw len gth . Rem ove th e Green Drill Sleeve
a n d in sert th e selected 4.0 m m fu lly
th rea ded Hu m era l Lockin g Screw th rou gh
th e 8.0 m m Brown Drill Sleeve with th e
DELTA Tibia l/ Hu m era l Hexdriver. In osteo-
porotic bon e, it m a y be n ecessa ry to pu t a
wa sh er on th e screw to preven t it from
bein g cou n tersu n k. Con firm a tion of th e
in terlockin g screw with in th e n a il is m a de
by in trodu cin g th e 2.4 m m Gu ide Rod
th rou gh th e dista l en d of th e n a il.
PROXI MAL I NTERLOCKI NG
Usin g th e im a ge in ten sifica tion , iden tify th e
ova l h ole in th e proxim a l en d of th e n a il
(Figure12). Ma ke a n in cision la tera lly
over th e proxim a l h u m eru s a n d u se blu n t
dissection down to bon e. Atta ch a 2.7 m m
Troca r to th e T-Ha n dled Ja cob' s Ch u ck
(Figure13). Use th e tip of th e Troca r to
fin d th e cen ter of th e ova l h ole of th e proxi-
m a l en d of th e n a il. Use th e Troca r to open
th e la tera l cortex of th e proxim a l h u m eru s.
In sert th e 2.7 m m Drill Bit th rou gh th e
2.7 m m Green Drill Sleeve
a n d 8.0 m m Ha n d-Held
Drill Sleeve, a n d in sert th is
a ssem bly in to th e h ole m a de
by th e Troca r.
21
Figure 11
Figure 12
11-5130
11-5118
11-5129
11-5117
11-0257
Figure 13
11-2096
S U R GI CA L T E CH N I QU E R E T R OGR A DE
Drill pa ra llel to th e bea m of th e im a ge
th rou gh th e ova l h ole in th e proxim a l en d
of th e n a il (Figure14). Ta ke ca re n ot to
drill th rou gh a rticu la r ca rtila ge in th e
h u m era l h ea d. Use th e Hu m era l Direct
Mea su rem en t Ga u ge to m ea su re th e len gth
of th e screw.
In sert th e 4.0 m m fu lly th rea ded h u m era l
screw th rou gh th e 8 m m Ha n d-Held Drill
Sleeve, a n d th rou gh th e ova l h ole in th e
proxim a l en d of th e n a il (Figure15).
Con firm con ta in m en t of th is screw with in
th e n a il, u sin g im a ge in ten sifica tion
(Figure16). Irriga te both proxim a l a n d
dista l in cision s with sa lin e. In sert a dra in
th rou gh th e skin if n ecessa ry a n d close th e
wou n d in la yers.
POSTOPERATI VE
Postopera tively, pla ce th e pa tien t in a lon g-
a rm posterior pla ster splin t a n d colla r a n d
cu ff. After two to th ree da ys, pa tien ts a re pu t
in a ca st bra ce if th ere is con cern a bou t sta -
bility. Active ra n ge of m otion exercises ca n
begin a t fou r to seven da ys.
22
Figure 16
Figure 14
Figure 15
S U R GI CA L T E CH N I QU E R E T R OGR A DE
EXTRACTI ON TECHNI QUE
HUMERAL NAI L
Extra ct th e R-T Hu m era l Na il by first a pply-
in g th e Extra ction Bolt to th e proxim a l en d
of th e n a il. Th en rem ove th e in terlockin g
screws th rou gh percu ta n eou s in cision s.
Fin a lly, a tta ch th e Driver/ Extra ctor tu be
a n d drive th e n a il ou t with th e slotted
h a m m er.
23
11-5127
11-5126
11-5175
I MP L A N T S
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NAI LS
Cat. No. Size
12-2450
12-2451
12-2452
12-2453
12-2454
12-2455
12-2456
12-2460
12-2461
12-2462
12-2463
12-2464
12-2465
12-2466
12-2470
12-2471
12-2472
12-2473
12-2474
12-2475
12-2476
7 m m x 18 cm
7 m m x 20 cm
7 m m x 22 cm
7 m m x 24 cm
7 m m x 26 cm
7 m m x 28 cm
7 m m x 30 cm
8 m m x 18 cm
8 m m x 20 cm
8 m m x 22 cm
8 m m x 24 cm
8 m m x 26 cm
8 m m x 28 cm
8 m m x 30 cm
9 m m x 18 cm
9 m m x 20 cm
9 m m x 22 cm
9 m m x 24 cm
9 m m x 26 cm
9 m m x 28 cm
9 m m x 30 cm
Gr een Color Code Str ipe.
PACKAGING LABEL
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26
4.0 MM LOCKI NG SCREW
Cat. No. Length
12-2912
12-2914
12-2916
12-2918
12-2920
12-2922
12-2924
12-2926
12-2928
12-2930
12-2932
12-2934
12-2936
12-2938
12-2940
12-2942
12-2944
12-2946
12-2948
12-2950
12-2952
12-2954
12-2956
12-2958
12-2960
12 m m
14 m m
16 m m
18 m m
20 m m
22 m m
24 m m
26 m m
28 m m
30 m m
32 m m
34 m m
36 m m
38 m m
40 m m
42 m m
44 m m
46 m m
48 m m
50 m m
52 m m
54 m m
56 m m
58 m m
60 m m
Length
I N S T R U ME N T S
27
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Nail Length Gauge
Cat. No. 11-2058
Cur ved Awl
Cat. No. 21-6600
Tip Thr eaded Guide Wir e
3.2 m m x 305 m m
Cat. No. 11-2057
Cannulated Reamer
9.0 m m
Cat. No. 11-2003
Pseudar thr osis Chisel
5.6 m m
Cat. No. 11-5128
T-Handle Jacob' s Chuck
Cat. No. 11-0257
Key for T-Handle Jacob' s Chuck
Cat. No. 7111-0258
( n ot sh own )
Inter changeable Sounds
Cat. No. Size
11-8190
11-8192
11-8194
11-8196
11-8198
11-8200
T-Handled Shaft for
Inter changeable Sounds
Cat. No. 11-8180
Humer al Scr ew Length Gauge
Cat. No. 11-5124
7 m m
8 m m
9 m m
10 m m
11 m m
12 m m
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Ball Tipped Reamer Guide Rod
2.0 m m x 700 m m ( for 6.0-7.5 rea m ers)
Cat. No. 11-5120
Reamer Template
Cat. No. 11-2023
Skin Pr otector
Cat. No. 41-5330
Humer al Medullar y
Exchange Tube
Cat. No. 11-5115
Nail Guide Rod
2.4 m m x 700 m m
Cat. No. 11-5123
Humer al Pr oximal Dr ill Guide
Cat. No. 11-5116
Replacement Bolt for Pr oximal
Dr ill Guide
Cat. No. 11-5113
Open End Wr ench
9/ 16" ( 2 in clu ded in set)
Cat. No. 11-0566
I N S T R U M E N T S
29
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Humer al Nail Dr iver
Cat. No. 11-5125
Slotted Hammer
Cat. No. 11-5175
8.0 mm Br own Dr ill Sleeve
Cat. No. 11-5122
2.7 mm Gr een Dr ill Sleeve
Cat. No. 11-5121
Tr ocar
2.7 m m x 216 m m
Cat. No. 11-5117
Dr ill Bit
2.7 m m x 216 m m
Cat. No. 11-5118
Hexdr iver Shaft for 4.0/ 4.5 mm Scr ews
Cat. No. 11-2096
Dr ill Sleeve with Handle
8.0 m m
Cat. No. 11-5129
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Humer al Dir ect
Measur ement Gauge
Cat. No. 11-5130
Self-Holding Attachment
( for 4.0, 4.5, a n d 5.0 m m
Lockin g Screws)
Cat. No. 11-2076
Humer al Extr actor Bolt
( Repla cem en t Bolt for Hu m era l Gu ide)
Cat. No. 11-5127
Humer al Dr iver / Extr actor Tube
Cat. No. 11-5126
Quick Release T-Handle
Cat. No. 11-6011
Inter changeable Sound System
Cat. No. 11-2146
Univer sal Socket Wr ench
Cat. No. 7111-1650
R-T Humer al Ster ilization Case
Cat. No. 7111-2140
31
Humer al Instr ument Set
Cat. No. 11-2141
( Not Sh own )
Includes the following:
Cat. No. Descr iption Qty.
11-0257 T-Handle Jacob' s Chuck 1
11-0566 9/ 16" Open End Wr ench 2
11-2003 9.0 mm Cannulated Reamer 1
11-2023 Reamer Template 1
11-2058 R-T Nail Length Gauge 1
11-2076 Self-Holding Attachment F/ Locking Scr ew 1
11-2096 Hexdr iver Shaft for 4.0/ 4.5 mm Locking Scr ews 1
11-5116 R-T Humer al Pr oximal Dr ill Guide ( Includes Bolt) 1
11-5121 2.7 mm Dr ill Sleeve ( Gr een) 1
11-5122 8.0 mm Dr ill Sleeve ( Br own) 1
11-5124 R-T Humer al Scr ew Length Gauge 1
11-5125 R-T Humer al Nail Dr iver 1
11-5126 R-T Humer al Dr iver / Extr actor Tube 1
11-5127 R-T Humer al Extr actor Bolt 1
11-5128 5.6 mm Pseudar thr osis Chisel 1
11-5129 R-T 8.0 mm Dr ill Sleeve W/ Handle 1
11-5130 R-T Humer al Dir ect Measur ing Gauge 1
11-5175 Slotted Hammer 1
21-6600 Cur ved Awl 1
41-5330 Skin Pr otector 1
11-2146 Inter changeable Sound System 1
11-6011 Quick Release T-Handle 1
7111-1650 9/ 16" Univer sal Socket Wr ench 1
7111-2140 R-T Humer al Ster ilization Case 1
Instr ument Tr ay
Cat. No. 7111-2140
Will hold the following:
Cat. No. Descr iption Qty.
11-0257 T-Handle Jacob' s Chuck 1
11-0566 9/ 16" Open End Wr ench 2
11-2003 9.0 mm Cannulated Reamer 1
11-2023 Reamer Template 1
11-2058 R-T Nail Length Gauge 1
11-2076 Self-Holding Attachment F/ Locking Scr ew 1
11-2096 Hex Dr iver for 4.0/ 4.5 mm Locking Scr ews 1
11-5115 R-T Humer al Medullar y Exchange Tube 1
11-5116 R-T Humer al Pr oximal Dr ill Guide ( Includes Bolt) 1
11-5121 2.7 mm Dr ill Sleeve ( Gr een) 1
11-5122 8.0 mm Dr ill Sleeve ( Br own) 1
11-5124 R-T Humer al Scr ew Length Gauge 1
11-5125 R-T Humer al Nail Dr iver 1
11-5126 R-T Humer al Dr iver / Extr actor Tube 1
11-5127 R-T Humer al Extr actor Bolt 1
11-5128 5.6 mm Pseudar thr osis Chisel 1
11-5129 R-T 8.0 mm Dr ill Sleeve W/ Handle 1
11-5130 R-T Humer al Dir ect Measur ing Gauge 1
11-5175 Slotted Hammer 1
21-6600 Cur ved Awl 1
41-5330 Skin Pr otector 1
11-6011 Quick Release T-Handle 1
11-2146 Inter changeable Sound System 1
7111-1650 Univer sal Socket Wr ench 1
I N S T R U M E N T S E T S
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32
IMPORTANT MEDICAL INFORMATION
Warnings and Precautions
RICHARDS INTRAMEDULLARY NAIL SYSTEM
IMPORTANT NOTE
Intramedullary nails provide an alternative to open reduction and fixation of a variety
of fractures. The objective of this closed technique as compared to open techniques
is to provide fixation with minimal trauma, reduced risk of infection, and reduced
blood loss. As with all orthopedic devices, success varies with the patient; even in
the less difficult case there is a risk of complications. The surgeon is cautioned that
any of the circumstances listed under categories below may reduce the chances of a
successful outcome.
BASIC STRUCTURE
The Richards Intramedullary Nail System consists of interlocking intramedullary
nails, interlocking reconstruction nails, and intramedullary hip screw systems. All of
these systems listed previously accept locking screws. The locking screws reduce
the likelihood of shortening and rotation of femoral shaft fractures. All nails are avail-
able in a variety of diameters and lengths. All implantable devices are for single use
only.
Intramedullary interlocking nails and femoral/recon nails are curved or straight
nails that contain holes proximally and distally to accept locking screws.
Interlocking reconstruction nails are curved nails that contain holes proximally to
accept screws which thread into the femoral head for compression and rotational
stability; distally there are two holes to accept locking screws. Interlocking recon-
struction nails are available in a variety of diameters and lengths in left and right
models, as proximal screw holes are anteverted 8with respect to the plane contain-
ing the curve of the nail.
Intramedullary hip screw systems contain a pre-bent nail containing holes proxi-
mally and distally to accept a lag screw and locking screws, respectively.
Intramedullary hip screws are available in a variety of diameters, lengths and
neck/shaft angles.
The ReVision Nail consists of an intramedullary nail with holes at each end to
accept 5.0 mm locking screws. The locking screws reduce the likelihood of shorten-
ing and rotation of the fusion site.
Interlocking retrograde nails have proximal and distal holes for locking screws.
MATERIALS
Intramedullary nails, locking screws, sleeves, draw bolts, set screws, and lag screws
are manufactured from stainless steel (ASTM F 138 and ISO 5832/1).
INDICATIONS, CONTRAINDICATIONS, AND
ADVERSE EFFECTS
General
The general principles of patient selection and sound surgical judgment apply to the
intramedullary nailing procedure. The size and shape of the long bones present limit-
ing restrictions on the size and strength of implants.
Indications for interlocking intramedullary nails include severely comminuted, spi-
ral, large oblique and segmental fractures; nonunions and malunions; and bone
lengthening/shortening. Femoral interlocking nails include the indication for proximal,
middle and distal third femoral shaft fractures. Tibial interlocking nails also include
the same indications for tibial shaft fractures.
Humeral interlocking intramedullary nails are indicated for humeral shaft frac-
tures, including severely comminuted, spiral, large oblique and segmental fractures;
nonunions and malunions, proximal, middle and distal third shaft fractures; poly-
trauma and/or multiple fractures; humerus reconstruction, following tumor resection
and grafting; and prophylactic nailing of impending pathologic fractures.
Forearm interlocking intramedullary nails are indicated for radial and ulnar shaft
fractures, including severely comminuted, spiral, large oblique and segmental frac-
tures; nonunions and malunions; proximal middle and distal third shaft fractures;
polytrauma and/or multiple fractures.
Interlocking reconstruction nails are indicated for the following: Subtrochanteric
fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck frac-
tures; severely comminuted shaft fractures; femur reconstruction following tumor
resection and grafting; bone shortening/lengthening; and prophylactic nailing of
impending pathologic fractures.
Femoral/recon antegrade nails are indicated for shaft fractures including severely
comminuted, spiral, large oblique and segmental fractures; nonunions and malu-
nions; bone lengthening/shortening; femur reconstruction following tumor resection
and grafting; fractures in osteoporotic bone; severely comminuted shaft fractures;
pathologic fractures, pseudoarthrosis, failed osteosynthesis; closed supracondylar
fractures; and prophylactic nailing of impending pathologic fractures. Additional indi-
cations for the femoral/recon antegrade include: subtrochanteric fractures with lesser
trochanteric involvement; ipsilateral femoral shaft/neck fractures.
Retrograde nails are indicated for shaft fractures including severely comminuted,
spiral, large oblique and segmental fractures; nonunions and malunions; bone
lengthening/shortening; femur reconstruction following tumor resection and grafting;
fractures in osteoporotic bone; severely comminuted shaft fractures; pathologic frac-
tures, pseudoarthrosis, failed osteosynthesis; closed supracondylar fractures; and
prophylactic nailing of impending pathologic fractures. Additional indications for retro-
grade nails include: severely comminuted supracondylar fractures with or without dif-
ficult intra-articular extension, fractures that require opening the knee joint to stabilize
the femoral condylar segment. Also, fractures above total knee implants.
Intramedullary hip screw systems are indicated for intertrochanteric and high sub-
trochanteric fractures, femoral neck fractures, and subcapital fractures. Indications
limited to the intramedullary hip screw long stem device only are comminuted neck
and shaft fractures, femur reconstruction following tumor resection, prophylactic nail-
ing of impeding pathologic fractures, and leg length discrepancies secondary to
femoral fracture.
Indications for the ReVision Nail include the following: degeneration, deformity, or
trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot: tibiocal-
caneal arthrodesis; combined arthrodesis of the ankle and sub-talar joints; avascular
necrosis of the talus following trauma; failed total ankle replacement with sub-talar
intrusion; failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis;
severe deformity secondary to untreated talipes equinovarus or neuromuscular dis-
ease; and severe pilon fractures with trauma to the sub-talar joint.
Contraindications
1. These systems should not be used in crossing open epiphyseal plates.
2. Insufficient quantity or quality of bone, obliterated medullary canal or conditions
which tend to retard healing, also, blood supply limitations, previous infections,
etc.
3. Foreign body sensitivity; where material sensitivity is suspected, appropriate
tests should be made and sensitivity ruled out prior to implantation.
4. Active infection.
5. Conditions which tend to impair the patients ability or willingness to restrict activ-
ities or to follow directions during the healing period.
6. The forearm nail should not be used in children who have not reached skeletal
maturity.
In addition to the contraindications listed above, reconstruction nails are also not rec-
ommended for any fracture which can be suitably fixed with a standard interlocking
intramedullary nail.
In addition to the contraindications listed above, intramedullary hip screw systems
are also contraindicated for a severe bow or gross distortion of the femur.
Possible Adverse Effects
1. Loosening, bending, cracking or fracture of the nails or screws, or loss of fixation
in bone attributable to nonunion, osteoporosis, markedly unstable comminuted
fractures or one or more of the factors listed in Contraindications above and/or
Warnings and Precautions, below.
2. Loss of anatomic position with nonunion or malunion with rotation or angulation.
3. Infections, both deep and superficial.
4. Allergies and other reactions to device materials.
5. Irritational injury of soft tissues, including impingement syndrome.
6. Supracondylar fractures from retrograde nailing.
WARNINGS AND PRECAUTIONS
WARNING: This device is not approved for screw attachment or fixation to the
posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Preoperative
1. Use care in handling and storage of implant components. Cutting, sharply bend-
ing or scratching the surface can significantly reduce the strength and fatigue
resistance of the implant system. This, in turn, could induce cracks and/or nonin-
ternal stresses that could lead to fracture of the implants. Implants and instru-
ments in storage should be protected from corrosive environments such as salt
air, moisture, etc. Inspection and trial assembly are recommended prior to
surgery to determine if instrument components or implants have been damaged
during storage or prior procedures.
2. Patient conditions and/or predispositions, such as those addressed in
Contraindications, above, should be avoided.
3. An adequate inventory of implant sizes should be available at the time of
surgery.
4. Allergies and other reactions to device materials, although infrequent should be
considered, tested for (if appropriate), and ruled out preoperatively.
5. Certain special surgical instruments are required to perform this surgery includ-
ing an image intensifier and an appropriate fracture table. Review of the use and
handling of these instruments is recommended.
6. Before the initial experience, we recommend that the surgeon acquaint himself
with the device and attend a technique seminar. Surgical technique brochures
are available upon request at no charge, and should be reviewed by the surgeon
prior to initial surgery. Skill in the use of this technique should be acquired on
less complicated fractures before attempting its use in unstable, difficult frac-
tures. The surgical technique provides reaming information for each nail.
7. The patient should be advised that a second more minor procedure for the
removal of implants is usually necessary.
Operative
1. Please refer to the surgical technique for the specific nail for important reaming
directions and modular nail assembly techniques.
2. Selection of the proper nail length and diameter is extremely important; the
patients age, weight and cortical bone quantity must be evaluated for the proper
implant selection. It should be noted that a small but consistent percentage of
complications due to nail fatigue failure remain. Therefore, it is always recom-
mended that the largest implant suitable for the patient be used.
3. Care should be taken not to scratch, bend sharply, or cut metal components dur-
ing surgery for the reasons stated in number one of the preoperative section of
Warnings and Precautions. Once removed from the patient, implants should
never be reused since internal stresses (in the implant) that are not visible may
lead to early bending or fracture.
4. A stable construct should be achieved and verified under image intensification.
5. For femoral interlocking intramedullary nails, the trochanteric entrance hole
should be in line with the femoral medullary canal in the lateral aspect of the
trochanteric fossa and not at the tip of the trochanter. An excessive lateral place-
ment of the entrance hole may result in eccentric reaming and comminution of
the medial cortex of the proximal fragment at the fracture site.
6. For tibial interlocking intramedullary nails, the entrance hole of the tibia should be
proximal to the tibia tubercle in the midline behind or slightly medial to the patel-
lar ligament. An excessive distal placement of the entrance hole may result in
entering the inner distal cortex at a steep angle and splitting the bone.
7. The use of Locking Screws is necessary for strength and compatibility. Please
refer to the surgical technique or product catalogue for information on the correct
size of screws for each nail.
8. For retrograde insertion of humeral interlocking intramedullary nails, nails are
inserted through a hole 1 cm wide by 2 cm long starting 2-3 cm proximal to the
olecranon fossa. The entry portal is in the lateral aspect of the greater tuberosity
for antegrade insertion. An incorrect entry portal will increase the chance of
breaking the humeral cortex during nail insertion.
9. For interlocking reconstruction nails, the proper sized proximal screws are nec-
essary. Both proximal screws should be used where possible for better fixation
of the femoral head.
10. In certain cases a bone graft may be appropriate.
11. For intramedullary hip screw systems, the intramedullary nail uses the Richards
standard lag screw proximally in conjunction with an intramedullary hip screw
sleeve and set screw.
12. For the ReVision Nail, the inner diameter of bone must be 1.0-1.5 mm larger
than the inserted nail whether reamed or not. Nail diameter sounds are avail-
able to determine inner bone diameter.
Postoperative
1. Intramedullary nails are neither intended to carry the full load of the patient
acutely, nor intended to carry a significant portion of the load for extended
periods of time.
Postoperative directions and warnings to patients by physicians and
appropriate nursing care are extremely important, particularly those admo-
nitions that concern early weight bearing or active use of the extremities.
These activities substantially increase the stress on implants that can lead
to complications. For this reason patients who are obese and/or noncom-
pliant, as well as patients who could be pre-disposed to delayed or non-
union, must have auxiliary support. The implant may be exchanged for a
larger, stronger nail subsequent to the management of soft tissue injuries.
2. Additional postoperative precautions should be taken when the fracture line
occurs within 5 cm of the nails screw hole, as this situation places greater stress
on the nail at the location of the transverse screw hole.
3. Supplemental support may be necessary for those patients using external
devices for ambulatory assistance.
4. Periodic X-ray examinations for at least the first six (6) months postoperatively
are recommended for close comparison with postoperative conditions to detect
changes in position, nonunion, loosening, bending or cracking of components.
With evidence of these conditions, patients should be closely observed, the pos-
sibilities of further deterioration evaluated, and the benefits of reduced activity
and early revision considered.
5. While the surgeon must make the final decision on implant removal, whenever
possible and practical for the individual patient, fixation devices should be
removed once their service as an aid to healing is accomplished. In the absence
of a bursa or pain, removal of the implant in elderly or debilitated patients is not
suggested.
6. Even after full healing, the patient should be cautioned that refracture is more
likely with the implant in place and soon after its removal, rather than later, when
voids in the bone left by implant removal have been filled in completely.
7. Patients should be cautioned against unassisted activity that requires walking or
lifting.
8. Postoperative care and physical therapy should be structured to prevent loading
of the operative extremity until stability is evident.
PACKAGING AND LABELING
All implants are provided sterile and should be accepted only if the factory packaging
and labeling arrive intact. If the sterile barrier has been broken, refer to the
Resterilization section below for additional instructions.
STERILIZATION
Metal components have been sterilized by a minimum of 25 kilo Grays of gamma
irradiation. Inspect packaging for punctures or other damage prior to surgery.
RESTERILIZATION
Metal components may be resterilized, if necessary, by steam autoclaving in appro-
priate protective wrapping, after removal of all the original packaging and labeling.
Protect prosthesis, particularly mating surfaces, from contact with metal or other hard
objects. The following process parameters are recommended for these devices:
Table 2: Sterilization Information - Pulsing Vacuum Cycle
Temperature 270- 275F
Pulse 1: Steam to 12 psig, vacuum to approximately 5"Hg.
Pulse 2: Steam to 12 psig, vacuum to approximately 20"Hg.
Pulse 3: Steam to 12 psig, vacuum to approximately 25"Hg.
Pulse 4: Steam 27-30 psig, exposure time 4.0 min. 5 sec.,
post vacuum 25"Hg.
INFORMATION
For further information, please contact Customer Service at (800) 238-7538 for calls
within the continental USA and (901) 396-2121 for all international calls.
Caution: Federal Law (USA) restricts this device to sale by or on the order of a
physician.
3433179 Rev. 0 1/97
The following statement is required by the U.S. FDA.
WARNI NG: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Ru ssel l - Ta yl or a n d DELTA a r e r egi st er ed t r a dem a r ks of Sm i t h & Neph ew, I n c. 1997 Sm i t h & Neph ew, I n c. 11/97 7118-0338
Sm ith & Neph ew, I n c. 1450 Br ooks Roa d Mem ph is, TN 38116 U.S.A.
( 901) 396- 2121 For in for m a tion : 1- 800- 821- 5700 For or der s a n d or der in qu ir ies: 1- 800- 238- 7538
www.sm ith n eph ew.com / or th opa edics