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THE SMITH & NEPHEW

TIBIAL INTERLOCKING NAILS
by
Thomas A. Russell, M.D.,
John Charles Taylor, M.D.,
and David G. LaVelle, M.D.
Memphis, Tennessee

TA BL E OF C O N T E N T S
Introduction................................................................. 2
Design Features – Standard Tibial Nail...................... 4
Design Features – DELTA® Tibial Nail ........................ 5
Surgical Technique...................................................... 6
Catalog Information.................................................... 19

Nota Bene: The technique description herein is made

available to the healthcare professional to illustrate the
authors’ suggested treatment for the uncomplicated
procedure. In the final analysis, the preferred treatment is
that which addresses the needs of the specific patient.

WARNING: This device is not approved for screw attachment or fixation to

the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

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I N T R O D U C T I O N

D
esigned by Drs. Toney Russell The closed section design of the inter-
and Charlie Taylor from locking nail overcomes the biomechani-
Memphis, Tennessee, the Smith cal shortcomings of a slotted nail and,
& Nephew Interlocking Nail System has therefore, inherently answers some of the
grown to include nails for various femur overall design goals. The elimination of
fractures (including subtrochanteric, the slot reduces complications by:
intertrochanteric, supracondylar, and
1. Decreasing torsional shear postopera-
ipsilateral neck/shaft), tibial fractures,
tively in the healing bone,
and humeral fractures. These nails are
closed section, cannulated, ASTM F-138 2. Increasing the amount of material
stainless steel, and allow interlocking around the screw holes,
screws to be placed above and below the 3. Reducing torsional rotation during
fracture site to prevent shortening and to insertion of the nail, and
maintain rotational control. The
4. Easing distal targeting.
standard locking screws are fully
threaded to ensure optimum bone Another equally important area in the
purchase and to prevent backing out. design of the interlocking nail concerned
the bending strength. This was especially
The Interlocking Nail System was
critical in light of the second overall
designed with two overall goals for the
design goal of the system: to extend the
healing of long bone fractures. The first
indications of intramedullary nailing. It
was to improve the clinical success of
was felt that smaller nails could be very
previously available interlocking nails by
useful in the treatment of open fractures
reducing complications. The second
and in treating small boned patients.
overall goal was to extend the indica-
However, before this could become a
tions of interlocking intramedullary
reality, “unreamed” interlocking nails
nailing to more complex fractures of the
would have to be stronger than their his-
femur (including ipsilateral neck/shaft,
torical counterparts which were reported
subtrochanteric, and pathologic frac-
to have higher breakage rates in nails of
tures), as well as complex fractures of
less than 13 mm in diameter.1,2,3
the tibia and humerus.
The practical manifestation of the atten-
The primary feature of the interlocking
tion to strength requirements can be
nail is the “non-slotted” or closed sec-
seen in the Interlocking DELTA® nails
tion design. This is different from the
and the DELTA II nails. These nails have
first widely accepted design for an IM
increased wall thickness in small diame-
nail which contained a longitudinal slot
ters in order to maintain strength while
beginning at the distal end and proceed-
avoiding the clinical problems of an
ing proximally either the full length of
overly stiff nail. Clinically these smaller
the nail or to within a few centimeters of
diameter interlocking nails have been
the proximal end.
very effective in the treatment of open

2
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fractures where they could be used
without reaming. They have also been
used as the nail of choice in patients
with small canals that could not have
easily withstood the excessive amount of
reaming necessary to insert a standard
diameter intramedullary nail.
I N T R O D U C T I O N
REFERENCES
1
Kyle, R.F.; and Latta, L.L.: Mechanics of Femoral
Intramedullary Nailing, AAOS Committee of
Biomechanical Engineering, Las Vegas, 1985.
2
Franklin, J.L.; Winquist, R.A.; Benirschke, S.K.;
and Hansen, S.T., Jr.: Broken Intramedullary
Nails. Journal of Bone and Joint Surgery, 70-A:
1463-1471, 1988.
3
Bucholz, R.W.: Dilemmas and Controversies in
Intramedullary Nailing in The Science and
Practice of Intramedullary Nailing, Ed. by
Browner, Bruce D. and Edwards, Charles C., Lea
and Febiger, 1987, Philadelphia, pg. 85-89.
3
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DESIGN FEATURES – R- T TIBIAL NAIL

THE RUSSELL-TAYLOR® (R-T)

Available in lengths of
TIBIAL NAIL 28.5 cm to 38 cm.
Positive lock keyway
(Upon request, certain
provides secure
The Interlocking Tibial Nails are avail- longer lengths are
instrument fit for
available.)
able in diameters of 11, 12, 13, and accurate proximal
targeting.
14 mm. The nails contain a 15˚ anterior
bend at a point 45 mm from the top of
the nail. This allows the nail to enter the 15O proximal bend.
anterior proximal portion of the tibia.
There is a 3˚ anterior bend in the distal
64 mm of the nail that serves as a
“ramp” for the nail during insertion,
thereby reducing the chance for poste-
rior cortical comminution. Proximally
and distally, the Tibial Nail uses 5.0 mm
fully threaded, self-tapping bone screws.
These allow for bi-cortical fixation in 11, 12, 13, and
14 mm diameters
order to reduce the possibility of the are available. Closed-section design for
torsional stability.
screws backing out.
Stable fractures of the isthmus (trans-
verse and short oblique uncomminuted
fractures) may be treated without lock-
ing screws. Fractures proximal to the
isthmus require two proximal locking
screws whereas more distal fractures
should be locked with two distal screws.
All unstable fractures should be locked
with two screws distally and proximally, R-T STANDARD R-T DELTA
The DELTA Design has increased wall
thereby maintaining length and pre- thickness to maintain the strength
venting rotation. The Tibial Nail has a integrity in the smaller diameter nail for
the treatment of open fractures and
unique Proximal Drill Guide that allows patients with small medullary canals.
for accurate nail insertion and place-
ment of the proximal screws. Designed
to address the widening spectrum of 3O distal bend.
indications for nailing fractures of the
Transfixing holes allow
tibia, the Tibial Nail allows for the proximal and distal
intramedullary fixation of tibial shaft interlocking with 5.0 mm
fully-threaded screws.
fractures including those that are seg-
mental or severely comminuted. If the Cold work expansion
of distal screw holes
canal is large enough, the Tibial Nail, for increased strength.
11-14 mm diameter, may be inserted
without reaming.

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DES IGN F EATURES–R-T DELTA TIBIAL NAIL

THE R-T DELTA TIBIAL NAIL

The Interlocking DELTA Tibial Nails are avail-
Positive lock keyway
provides secure instru- able in shaft diameters of 8, 9, and 10 mm.
ment fit for accurate 12 mm proximal
diameter. The proximal end of these nails is tapered to
proximal targeting.
12 mm to give the extra strength necessary for
nail insertion and proximal interlocking. The
15O proximal bend.
nails contain a 15˚ anterior bend at a point
45 mm from the top of the nail. This allows
the nail to enter the anterior proximal portion
of the tibia. There is a 3˚ anterior bend in the
Available in lengths of
27 cm to 36 cm. (Upon distal 64 mm of the nail that serves as a
request, certain longer “ramp” for the nail during insertion, thereby
lengths are available.)
Closed-section design for reducing the chance for posterior cortical
torsional stability. comminution. Proximally and distally, the
DELTA Tibial Nail uses 4.5 mm fully threaded,
self-tapping bone screws. These allow for
8, 9, and 10 mm bicortical fixation in order to reduce the possi-
diameters are available.
bility of the screws backing out. Indications
for the DELTA Tibial Nail are the same as
those listed for the Standard Tibial Nail.
The DELTA Tibial Nails may be inserted
reamed or unreamed. The unique combina-
tion of strength and smaller size offered in
this implant gives particular advantages in
the treatment of open fractures, patients with
small medullary canals, and congenital
problems. If the canal is large enough, a
DELTA Tibial Nail, 8-10 mm diameter, may
be inserted without reaming.
Transfixing holes allow NOTE: Due to the smaller diameter and con-
proximal and distal
interlocking with 4.5 mm sequent reduction in strength of the 8 mm
fully-threaded screws.
DELTA Tibial Nails, these implants are
intended to be nonweight bearing devices.
Auxiliary support with a PTB cast or orthosis
is necessary. The patient must be cautioned
Cold work expansion against significant weight bearing prior to
of distal screw holes
for increased strength.
good callus formation. The implant may be
3O distal bend. exchanged for a larger, stronger nail subse-
quent to the management of soft tissue
injuries. If a reamed technique is to be used,
it is recommended that a 9 mm diameter or
larger nail be implanted.

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S U R G I C A L T E C H N I Q U E

PREOPERATIVE PLANNING
Preoperative radiographs of the unin-
jured tibia may be used to establish
proper nail diameter, expected amount
of reaming, and final nail length for
severely comminuted fractures. X-ray
templates for the R-T Tibial Nail and the
R-T DELTA Tibial Nail are available for
preoperative planning. The nail length
should permit the proximal end to be
countersunk with the distal end centered
in the distal epiphysis.
Distraction of the diaphyseal fracture
must be attained with traction before ini-
tiating closed antegrade intramedullary
nailing (except in acute cases).
Further impaction is occasionally seen
when severely comminuted fractures are
later dynamized. This risk should be
considered during selection of nail
length to prevent later nail migration
into the ankle or nail protrusion out of
the proximal tibia.
The nail size used depends on the size of
the patient and the extent of tibial com-
minution. It should be noted, however,
that a small but consistent percentage of Fractures situated in the shaded area can
be treated with the R-T Tibial or the
complications due to nail fatigue failure DELTA Tibial Interlocking Nail.
remain. Therefore, it is always recom-
mended that the largest implant suitable
for the patient be used.
NOTE: 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. All patients
should be cautioned against significant
weight bearing prior to good callus for-
mation. For this reason, patients who are
obese and/or noncompliant, as well as
patients who could be predisposed to
delayed or nonunions, must have auxil-
iary support.

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S U R G I C A L T E C H N I Q U E

PATIENT POSITIONING
Place the patient in a supine position on
the fracture table; a well padded bar
beneath the distal thigh. The hip should
be flexed at approximately 70˚-90˚ and
the knee flexed at such an angle to allow
a horizontal orientation of the tibia
(C-arm manipulation is easier with a
horizontal tibia.) Rotational alignment
is achieved by aligning the iliac crest,
patella, and second ray of the foot. Apply
traction through either a calcaneal trac-
tion pin or special foot holder (Figure 1) .
For simple nailing, the surgeon may
stand medial or lateral with the C-arm
opposite the surgeon. For interlocking, it
is necessary to have access to medial and
lateral aspects of the leg, with the C-arm
brought in from the lateral.

PATIENT PREPARATION
Scrub and prepare the patient in the
standard manner. Drape the affected
lower extremity from the distal thigh to
the calcaneal traction pin. Cover the
image intensifier arm with a sterile
isolation drape.

Figure 1

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S U R G I C A L T E C H N I Q U E

SURGICAL APPROACH AND TIBIAL

PREPARATION
Make a 5 cm incision medial to the patellar
ligament. Using the Curved Awl, open the
medullary canal proximal to the tibial
tuberosity, in the midline behind or slightly
medial to the patellar ligament (Figure 2) .
An excessively distal placement of the entry
site may result in entering the tibia at too
21-6600
steep an angle and either splitting the tibia,
or breaking out through the posterior cor-
tex. Ream the proximal fragment of the Figure 2
41-5330
tibia to 12 mm diameter using the Skin
Protector while reaming.
11-2021

GUIDE ROD INSERTION AND

REDUCTION
7111-8217
To assist in fracture reduction or the
reamed technique, three unique
3.2 mm Guide Rods are available. Simple
fractures will utilize the Straight Guide
Rod while more severely displaced
fractures may require the use of
the Curved Tip Guide Rod. For
obstructed intramedullary canals, the cut-
11-5057 ting edge of the Spade Tip Guide Rod may
be helpful in obtaining shaft reduction. Use
the 3.0 mm Guide Rod for the unreamed
11-2007 technique.
Introduce the selected Guide Rod by means
of the T-Handle Jacob’s Chuck to the level Figure 3
11-2059 of the fracture. Confirm its containment
within the tibia by means of A-P and lateral
views. Reduce the proximal fragment to the
distal fragment by means of the
Internal Fracture Alignment Device.
Advance the Guide Rod until it is cen-
tered in the distal fragment 0.5–1.0 cm
proximal to the ankle joint (Figure 3).
11-0257

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S U R G I C A L T E C H N I Q U E

Remove the Internal Fracture

Alignment Device. Verify containment
of the Guide Rod within the tibia by
image intensification.
Using the flexible reamers over a Guide
Rod, ream the entire tibia in 0.5 mm
increments until the desired diameter 11-0257

has been achieved (Figure 4) . The final

reamer diameter should be verified with
the Reamer Template.
Figure 4 The R-T Tibial Nails are 0.2 mm larger in
diameter than their stated size and DELTA
Tibial Nails are 0.1 mm larger in diameter
than their stated size. Therefore, select a
nail 1 mm to 1.5 mm smaller than the final
reamer used. Never insert a nail that has a 11-2023
larger diameter than the last reamer used.
Introduce the Medullary Exchange Tube
over the Reamer Guide Rod to maintain
fracture reduction. Replace the Reamer
Guide Rod with a 4 mm Nail Guide Rod.
Remove the Medullary Exchange Tube.
D E LTA
Use a 3 mm Nail Guide Rod for the
11-2020
DELTA Tibial Nail.

11-5115
NAIL SELECTION
For the unreamed technique, Inter- 11-2060
changeable Sounds can be used to deter-
mine the diameter of the canal and
proper nail size prior to insertion of the
nail (Figure 5) . Sounds are mounted to
the T-Handle Shaft and inserted manu-
ally over the 3.2 mm ball tip guide rod
and NOT DRIVEN. If resistance is
Figure 5 encountered, STOP, and withdraw the
Sound. The largest diameter Sound that

11-8180

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S U R G I C A L T E C H N I Q U E

can pass easily through the isthmus is

the correct diameter for the nail.
Preoperative estimates of canal diameter
should be obtained as a secondary esti-
mate of the correct nail diameter. Never
insert a nail that has a larger diameter
than the last Sound used.
Uncomminuted distal fractures may
require a smaller diameter nail or Figure 6
reaming as compared to comminuted
isthmus fractures because of the long
interference fit within the canal.
Verification of the proper nail length
may be determined by two separate
methods.

11-2058
— Nail Length Gauge
Position the Nail Length Gauge anterior
to the tibia (unaffected tibia preopera-
tively; affected tibia intraoperatively)
with its distal end centered in the distal
epiphysis. Move the C-arm to the proxi-
mal end of the tibia and read from the
image intensifier the correct nail length
directly from the stamped measurements
on the Nail Length Gauge (Figure 6) .
— Guide Rod Method Figure 7

With the distal end of the Guide Rod

centered in the distal epiphysis, overlap
a second Guide Rod to the portion of the
reduction Guide Rod extending proxi-
mally from the tibial entry portal.
Subtract the length (XXX mm) of the
overlapped Guide Rods from 900 mm to
determine the nail length (Figure 7) .

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S U R G I C A L T E C H N I Q U E

Supine Driver
NAIL INSERTION
Attach the selected nail to the Proximal
Drill Guide with the Hexagonal Bolt
Nail (Figure 8) . When assembled properly,
the keyed post of the Proximal Drill
Hexagonal Bolt 11-2025
Guide will be positioned on the medial
side of the nail (Figure 9) . Next attach
the Supine Driver to the Hexagonal Bolt
of the guide. Tighten with an Open End
Proximal
Drill Guide Wrench. Using the handle to control nail
rotation, insert the nail by tapping the
Slotted Hammer on the Supine Driver
Figure 8 Drill Sleeves
(Figure 10) . It is very important to 11-2024
NEVER HIT directly on the Proximal Drill
Guide; use the insertion instruments only.

11-0564

Figure 9

11-5175

Figure 10

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S U R G I C A L T E C H N I Q U E

Withdraw the Guide Rod. (It is necessary

to remove the Guide Rod before final
seating to prevent incarceration.)
Continue inserting the nail until the
proximal tip of the nail is flush with the
tibial entry portal (Figure 11) . Should
extraction of the nail be necessary,
attach the Extractor Tube to the Supine
11-2008
Driver and apply backward blows with
the Slotted Hammer. Be careful to avoid Figure 11
levering the nail/tube assembly.

PROXIMAL INTERLOCKING R-T

TIBIAL NAIL
Proximal and distal interlocking involves
the use of 5.0 mm locking screws. There-
11-2004 fore, the 4.0 mm Trocar, 4.0 mm Tibial
Drill, Green and Gold Drill Sleeves, and
the 5.0 mm Hexdriver Shaft are required.
Insert the 8 mm Green Drill Sleeve
11-2049 through the superior hole in the Figure 12

Proximal Drill Guide to determine the

proper location of the incision. Remove
the Green Drill Sleeve. Make a skin inci-
sion on the medial side to bone. Insert
the 8 mm Green and 4 mm Gold Drill
Sleeves. Attach the 4 mm Trocar to the
T-Handle Jacob’s Chuck. Insert the
11-2056 4 mm Trocar into the Gold Drill Sleeve
11-2012 and dimple the cortex (Figure 12) .
Remove the Trocar. Insert the 4 mm
Tibial Drill and drill through both cor-
tices; make depth measurements using
the 4 mm Tibial Drill calibrations and
read the length against the top of the
Figure 13
Gold Drill Sleeve (Figure 13) . Withdraw
the Gold Drill Sleeve.

11-5059

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S U R G I C A L T E C H N I Q U E

The locking screw length may be con-

firmed by using the Depth Gauge and
reading the length against the top of the
Green Drill Sleeve (Figure 14) . The
Drill Sleeves must be against the cortex
for accurate reading. Connect the Quick
11-6011
Connect T-Handle to the 5.0 mm
Hexdriver Shaft. Insert the selected
Figure 14 5.0 mm self-tapping screw through the
Green Drill Sleeve (Figure 15) . Repeat
the procedure for the second proximal
screw.

D E LTA

PROXIMAL INTERLOCKING
R-T DELTA TIBIAL NAIL 11-2085

The procedure for proximal and distal 11-2087

interlocking for the R-T DELTA Tibial
Nail is identical to the R-T Tibial Nail.
However, several product and instru-
ment size substitutions are necessary:
4.5 mm locking screws versus 5.0 mm locking
screws
Figure 15 3.5 mm Trocar versus the 4.0 mm Trocar
3.5 mm Tibial Drill versus the 4.0 mm Tibial
Drill
3.5 mm Black Drill Sleeve versus 4.0 mm Gold
Drill Sleeve 11-2086
4.0/4.5 mm Hexdriver Shaft versus 5.0 mm
Hexdriver Shaft

11-2096

11-5058

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S U R G I C A L T E C H N I Q U E

FREEHAND TECHNIQUE FOR Using a slotted hammer, drive the guide

pin to the lateral side of the rod. Remove
DISTAL TARGETING the T-handle chuck from the guide pin
The most frequently used technique for and obtain a lateral image of the femur.
distal targeting of screws is the freehand The guide pin should point directly to
technique as described by Robert F. Hall, the center of the hole within the rod. If
Jr., M.D., Chairman, Division of this is not the case, make adjustments as
Orthopaedic Surgery, Cook County necessary. Once proper alignment has
Hospital, Chicago, Illinois. been obtained, withdraw the guide pin;
Place the image intensifier in the lateral place the drill in the previously made
position and scan the distal area. A true hole, and drill through the rod and
lateral image should be noted and the opposite cortex.
screw holes should be circular. Other- Determine the length of the screw using
wise, adjust leg rotation to obtain a true the Screw Depth Gauge. Place the screw
lateral image of the rod. When the holes in its proper position. Repeat the proce-
are completely circular, center a ring dure on the distal screw hole. The last
forceps over the proximal hole on the image should be that of a lateral, con-
lateral side of the leg. Then introduce a firming satisfactory placement of the
#10 blade within the confines of the ring screws.
forceps; make a longitudinal incision
along the midline axis of the leg, carry- DELTA
ing the incision down to bone. Repeat
the procedure on the distal screw hole. FREEHAND TECHNIQUE FOR
Connect the two incisions with an DISTAL TARGETING
approximately 3 cm long incision,
Same as standard nail, but substitute
which is carried down to the bone.
the 3.5 mm trocar for the 4.0 mm
Place a 4.0 mm trocar attached to the guide pin.
T-handle chuck, angled at 45˚ over the
proximal screw hole. Using the image
intensifier, adjust the guide pin until the
point is centered over the screw hole.
Return the image intensifier to the ante-
rior-posterior view and maintain con-
stant pressure on the guide pin to pre-
vent skidding. Swing the guide pin
perpendicular to the axis of the bone.
Adjust the angle on the A-P image so
that the guide pin will be driven towards
the hole in the nail. Now the guide pin is
lined up both in the lateral and the A-P
planes.

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S U R G I C A L T E C H N I Q U E

COLE RADIOLUCENT DRILL — ABBREVIATED TECHNIQUE

1 2
Attach the handle for Select the proper
use as left-handed or drill bit size and
right-handed. insert tapered end
into the drill.

5 6
Attach power drill to the Place drill bit onto
Cole Radiolucent Drill. the skin.
Tighten with a T-handled
chuck key.

9 10
Rotate the Cole Radio- Verify concentric posi-
lucent Drill parallel or tion of the drill bit in
in line with the C-arm. the hole of the nail
and two opaque rings.
Drill through bone.

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S U R G I C A L T E C H N I Q U E

3 4
Place the locking cap over Use the T-handled chuck
the drill bit with one hand key over the chuck end
while preventing rotation of the Cole Radiolucent Drill
of the hollow tube with to prevent the shaft from
the other hand. rotating. Tighten the locking
cap. Remove T-handled
chuck key.

7 8
Use image After making an incision to bone
intensification and placing the drill bit on bone,
to verify center bit within the perfect circle
placement with long axis of bit perpendicular
in the center to long axis of nail.
of the perfect
circle.

11 12
After drilling, slide the screw Remove drill. Insert
length sleeve over the drill bit. correct size bone screw.
Read correct screw length from
top of screw length sleeve.

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S U R G I C A L T E C H N I Q U E

POSTOPERATIVE CARE NAIL REMOVAL

Dynamization means removal of either To extract the nail, remove the locking
the proximal or distal locking screws to screws and attach the Extractor Bolt to
allow axial loading of the tibia. There is the proximal end of the nail. Then
no certain time interval when dynamiza- attach the Extractor Tube and apply
tion should occur. However, a general backward blows with the slotted ham-
guideline would be about 12 weeks post- mer. Be careful to avoid levering the
operatively. Dynamization is not always nail/tube assembly. See Extraction
indicated to promote fracture healing Technique (62-11752) for more details.
and certainly dynamization should not
be considered if it will compromise the
tibial construct. Refer to the Warnings
and Precautions Section of Important
Medical Information in this brochure for
additional information on postoperative
care.
In nails locked in the dynamic mode, the
locking screws are removed at the same
time of nail removal. In a nail locked
statically, the surgeon should decide on
which screws, either proximal or distal,
are contributing most to fracture stabil-
ity and remove the less critical screw if
dynamization is indicated. The patient
should not be permitted to fully weight
bear on the operative leg locked in the
static mode acutely. Weight bearing of a
patient with dynamic interlocking pro-
gresses according to stability of the frac-
ture. Weight bearing status is increased
based on the X-ray and clinical findings
of the healing of the fracture site.

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I M P L A N T S

R-T TIBIAL
INTERLOCKING NAILS
R-T Tibial Interlocking Nails are
0.2 mm larger in diameter than
their stated size.
Gold Color – Code Stripe
Cat. No. Diameter Length
12-2184 11 mm 28.5 cm
12-2185 11 mm 30.0 cm
12-2186 11 mm 31.5 cm
12-2187 11 mm 33.0 cm
12-2188 11 mm 34.5 cm
12-2189 11 mm 36.0 cm
12-2190 11 mm 38.0 cm
12-2211* 11 mm 40.0 cm
12-2212* 11 mm 42.0 cm
12-2191 12 mm 28.5 cm
12-2192 12 mm 30.0 cm
12-2193 12 mm 31.5 cm
12-2194 12 mm 33.0 cm
12-2195 12 mm 34.5 cm
12-2196 12 mm 36.0 cm
12-2197 12 mm 38.0 cm
12-2214* 12 mm 40.0 cm
12-2215* 12 mm 42.0 cm
PACKAGING LABEL
12-2204 13 mm 28.5 cm
12-2198 13 mm 30.0 cm
12-2199 13 mm 31.5 cm
12-2200 13 mm 33.0 cm
12-2201 13 mm 34.5 cm
12-2202 13 mm 36.0 cm
12-2203 13 mm 38.0 cm
12-2205 14 mm 30.0 cm
12-2206 14 mm 31.5 cm
12-2207 14 mm 33.0 cm
12-2208 14 mm 34.5 cm
12-2209 14 mm 36.0 cm
12-2210 14 mm 38.0 cm
*Available upon request.

5.0 MM LOCKING SCREWS

5.0 mm Dia. Cat. No. Length
12-2280 25 mm
Length 12-2281 30 mm
12-2282 35 mm
12-2283 40 mm
12-2284 45 mm
12-2285 50 mm
12-2286 55 mm
12-2287 60 mm
12-2288 65 mm

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I M P L A N T S

R-T DELTA TIBIAL

INTERLOCKING NAILS Black Color – Code Stripe
R-T DELTA Tibial Interlocking Nails are
0.1 mm larger in diameter than
their stated size.

Cat. No. Diameter Length

12-2050 8 mm 27.0 cm
12-2051 8 mm 28.5 cm
12-2052 8 mm 30.0 cm
12-2053 8 mm 31.5 cm
12-2054 8 mm 33.0 cm
12-2055 8 mm 34.5 cm
12-2056 8 mm 36.0 cm
12-2057* 8 mm 38.0 cm
12-2058* 8 mm 40.0 cm
12-2059* 8 mm 42.0 cm
12-2170 9 mm 27.0 cm
12-2171 9 mm 28.5 cm
12-2172 9 mm 30.0 cm
12-2173 9 mm 31.5 cm
PACKAGING LABEL
12-2174 9 mm 33.0 cm
12-2175 9 mm 34.5 cm
12-2176 9 mm 36.0 cm
12-2218* 9 mm 38.0 cm
12-2219* 9 mm 40.0 cm
12-2166* 9 mm 42.0 cm
12-2177 10 mm 27.0 cm
12-2178 10 mm 28.5 cm
12-2179 10 mm 30.0 cm
12-2180 10 mm 31.5 cm
12-2181 10 mm 33.0 cm
12-2182 10 mm 34.5 cm
12-2183 10 mm 36.0 cm
12-2168* 10 mm 38.0 cm
12-2169* 10 mm 40.0 cm
12-2167* 10 mm 42.0 cm
*Available upon request.

4.5 MM LOCKING SCREWS 4.5 mm Dia.

Cat. No. Length
12-2290 20 mm Length
12-2291 25 mm
12-2292 30 mm
12-2293 35 mm
12-2294 40 mm
12-2295 45 mm
12-2296 50 mm
12-2297 55 mm
12-2298 60 mm
12-2299 65 mm

20
7118-0339 RT Delta ST 6/11/99 9:49 AM Page 21 (1,1)

I N S T R U M E N T S

Curved Awl
Cat. No. 21-6600

Blunt Medullary Reamer

Cat. No. 11-9657

Skin Protector
Cat. No. 41-5330

Tibial Entry Portal

Cat. No. 7111-8217

Guide Rod for Reamer – Curved Tip

3.2 mm x 900 mm
Cat. No. 11-5057

Guide Rod for Reamer – Straight

with Ball Tip
3.2 mm x 900 mm
Cat. No. 11-2021

Guide Rod for Reamer – Spade Tip

3.2 mm x 900 mm
Cat. No. 11-2007

T-Handle Jacob’s Chuck

Cat. No. 11-0257

Internal Fracture Alignment Device

Cat. No. 11-2018

21
7118-0339 RT Delta ST 6/11/99 9:49 AM Page 22 (1,1)

I N S T R U M E N T S

Reamer Template
Cat. No. 11-2023

Nail Length Gauge

Cat. No. 11-2058

Medullary Exchange Tube

Cat. No. 11-5115

Guide Rod for Nail

4 mm x 900 mm
Cat. No. 11-2020

Guide Rod for Nail

3 mm x 900 mm
Cat. No. 11-2059

Replacement Bolt
Cat. No. 11-2094

Tibial Proximal Drill Guide W/Bolt

Cat. No. 11-2025

Supine Driver
Cat. No. 11-2024

11/16" Open End Wrench

Two Required
Cat. No. 11-0564

22
7118-0339 RT Delta ST 6/11/99 9:49 AM Page 23 (1,1)

I N S T R U M E N T S

Slotted Hammer
Cat. No. 11-5175

Percutaneous Knife Handle

Cat. No. 11-2037

8 mm Drill Sleeve (Green)

Cat. No. 11-2012

4 mm Drill Sleeve (Gold)

Cat. No. 11-2056

Trocar for 5 mm Screws

Cat. No. 11-2004

Tibial Drill
4 mm x 305 mm
Cat. No. 11-2049

Screw Length Gauge

Cat. No. 11-5058

23
7118-0339 RT Delta ST 6/11/99 9:49 AM Page 24 (1,1)

I N S T R U M E N T S

Hexdriver Shaft 4.0/4.5 mm

Cat. No. 11-2096

Hexdriver Shaft 5.0 mm

Cat. No. 11-5059

Quick Connect T-Handle

Cat. No. 11-6011

3.5 mm Drill Sleeve (Black)

Cat. No. 11-2086

3.5 mm Disposable Trocar Pin

Cat. No. 11-2085

DELTA Tibial Drill

3.5 mm x 254 mm
Cat. No. 11-2087

Tibial/DELTA Tibial Extractor Bolt

Cat. No. 11-2041

Tibial Nail Driver/Extractor Tube

Cat. No. 11-2008

24
7118-0339 RT Delta ST 6/11/99 9:49 AM Page 25 (1,1)

I N S T R U M E N T S

Flexible T-Handle Shaft for Sounds

Cat. No. 11-8180

R-T Nail Interchangeable Sounds

for DELTA Tibial Nails
Cat. No. Description
11-8192 8 mm
11-8194 9 mm
11-8196 10 mm
11-8198 11 mm
11-8200 12 mm

Cole Radiolucent Drill

Cat. No. 11-0240
(Includes 11-0247 and 11-0248)

Replacement Locking Cap

Cat. No. 11-0247

Replacement Handle
Cat. No. 11-0248

Radiolucent Drill Bits

Cat. No. Size
11-0242 2.7 mm
11-0244 3.5 mm
11-0245 4.0 mm
11-0246 4.8 mm

25
7118-0339 RT Delta ST 6/11/99 9:49 AM Page 26 (1,1)

I N S T R U M E N T C A S E S

Tibial Instruments Sterilizing Case

Cat. No. 11-2078

Tibial Tray Components

(not shown)
Cat. No. Description
51-2000 Tibial Implant, Case Lid
51-2001 Tibial Implant, Nail Tray
51-2002 Tibial Implant, Screw Tray
51-2003 Tibial Implant, Case Lid, Nail, and Screw Tray

R-T DELTA/Tibial Instrument Set R-T Flexible Reamer Set Without Sounds
(not shown) (not shown)
Cat. No. 11-2006 Cat. No. 11-2145

Cat. No. Description Qty. Cat. No. Description Qty.

11-0257 T-Handle Jacob’s Chuck 1 11-5128 5.6 mm Pseudarthrosis Chisel 1
11-0564 11/16" Open End Wrench 2 11-8100 6.0 mm Flexible Reamer–End Cut 1
11-2004 Trocar for 5 mm Screws 3 11-8101 6.5 mm Flexible Reamer–Pilot Nose 1
11-2007 Guide Rod for Reamer–Spade Tip 3.2 mm x 900 mm 3 11-8102 7.0 mm Flexible Reamer–End Cut 1
11-2008 Tibial Nail Driver/Extractor Tube 1 11-8103 7.5 mm Flexible Reamer–Pilot Nose 1
11-2012 8.0 mm Drill Sleeve (Green) 1 11-8104 8.0 mm Flexible Reamer–End Cut 1
11-2018 Internal Fracture Alignment Device 1 11-8105 8.5 mm Flexible Reamer–Pilot Nose 1
11-2020 Guide Rod For Nails–Straight 4.0 mm x 900 mm 3 11-8107 9.0 mm Interchangeable Reamer Head–End Cut 1
11-2021 Guide Rod For Reamer–Straight 3.2 mm x 900 mm 3 11-8108 9.0 mm Interchangeable Reamer Head–Pilot Nose 1
11-2023 Reamer Template 1 11-8109 9.5 mm Interchangeable Reamer Head–Pilot Nose 1
11-2024 Supine Driver 1 11-8110 10.0 mm Interchangeable Reamer Head–Pilot Nose 1
11-2025 Tibial Proximal Drill Guide with Bolt 1 11-8111 10.5 mm Interchangeable Reamer Head–Pilot Nose 1
11-2037 Percutaneous Knife Handle 1 11-8112 11.0 mm Interchangeable Reamer Head–Pilot Nose 1
11-2041 Tibial/DELTA Tibial Extractor Bolt 1 11-8113 11.5 mm Interchangeable Reamer Head–Pilot Nose 1
11-2049 Tibial Drill 4.0 mm x 305 mm 3 11-8114 12.0 mm Interchangeable Reamer Head–Pilot Nose 1
11-2056 4.0 mm Drill Sleeve (Gold) 1 11-8115 12.5 mm Interchangeable Reamer Head–Pilot Nose 1
11-2058 Nail Length Gauge 1 11-8116 13.0 mm Interchangeable Reamer Head–Pilot Nose 1
11-2059 DELTA Guide Rod for Nail 3.0 mm x 900 mm 3 11-8117 13.5 mm Interchangeable Reamer Head–Pilot Nose 1
11-2078 Tibial Instruments Sterilizing Case 1 11-8118 14.0 mm Interchangeable Reamer Head–Pilot Nose 1
11-2086 DELTA 3.5 mm Drill Sleeve (Black) 1 11-8119 14.5 mm Interchangeable Reamer Head–Pilot Nose 1
11-2087 DELTA Tibial Drill 3.5 mm x 254 mm 1 11-8120 15.0 mm Interchangeable Reamer Head–Pilot Nose 1
11-2096 DELTA Hexdriver Shaft for 4.0/4.5 mm Screws 1 11-8121 15.5 mm Interchangeable Reamer Head–Pilot Nose 1
11-5057 Guide Rod for Reamer–Curved Tip 3.2 mm x 900 mm 3 11-8122 16.0 mm Interchangeable Reamer Head–Pilot Nose 1
11-5058 Screw Length Gauge 1 11-8123 16.5 mm Interchangeable Reamer Head–Pilot Nose 1
11-5059 Hexdriver Shaft 5.0 mm 1 11-8124 17.0 mm Interchangeable Reamer Head–Pilot Nose 1
11-5175 Slotted Hammer 1 11-8125 17.5 mm Interchangeable Reamer Head–Pilot Nose 1
11-6011 Quick Release T-Handle 1 11-8126 18.0 mm Interchangeable Reamer Head–Pilot Nose 1
11-9657 Blunt Medullary Reamer 1 11-8127 18.5 mm Interchangeable Reamer Head–Pilot Nose 1
21-6600 Curved Awl 1 11-8128 19.0 mm Interchangeable Reamer Head–Pilot Nose 1
41-5113 Medullary Exchange Tube 1 11-8129 19.5 mm Interchangeable Reamer Head–Pilot Nose 1
41-5330 Skin Protector 1 11-8130 20.0 mm Interchangeable Reamer Head–Pilot Nose 1
11-8131 20.5 mm Interchangeable Reamer Head–Pilot Nose 1
11-8132 21.0 mm Interchangeable Reamer Head–Pilot Nose 1
11-8150 Small Flexible Shaft 2
11-8151 Large Flexible Shaft 2
11-8165 5.0 mm T-Handle Reamer 1
11-8167 6.0 mm T-Handle Reamer 1
11-8230 Flexible Reamer/Sound Case 1

26
7118-0339 RT Delta ST 6/11/99 9:49 AM Page 27 (1,1)
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 8° with 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, appro priate
tests should be made and sensitivity ruled out prior to implantation.
4. Active infection.
5. Conditions which tend to impair the patient’s 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.
27
7118-0339 RT Delta ST 6/11/99 9:49 AM Page 28 (1,1)
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
patient’s 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.
3433179 Rev. 0
28
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 nail’s 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° - 275° F
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.
1/97
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Smith & Nephew, Inc. • 1450 Brooks Road • Memphis, TN 38116 U.S.A.
(901) 396-2121 • For information: 1-800-821-5700 • For orders and order inquiries: 1-800-238-7538

THE FOLLOWING STATEMENT IS REQUIRED BY THE U.S. FDA:

WARNING: This device is not approved for screw attachment or screw fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. Please refer to package insert for limitations.
Russell-Taylor and DELTA are registered trademarks of Smith & Nephew, Inc. ©1997 Smith & Nephew, Inc.
The Cole Radiolucent Drill was developed in conjunction with J. Dean Cole, M.D., Matthews Orthopaedic Clinic, Orlando, Florida. 10/97 7118-0339
7118-0339 RT Delta ST 6/11/99 9:49 AM Page 31 (1,1)

S M I T H & N E P H E W

THE SMITH & NEPHEW

TIBIAL INTERLOCKING NAILS

S U R G I C A L T E C H N I Q U E