Johnson & Johnson DePuy Mitek Rigidfix 104144 User manual

RIGIDFIX® FEMORAL
3.3mm ST CROSS
PIN KIT
DePuy Mitek, Inc.
325 Paramount Drive
Raynham, MA 02767, USA
1-800-356-4835
DePuy International Ltd.
St Anthony’s Road,
Leeds LS11 8DT England
Tel: [phone]
Fax: [phone]
P/N: 104144 Rev: K 01/10

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Figure 1 Figure 1A Figure 2
PROCEDURE INSTRUCTIONS

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Figure 3
Use spacer only if using 5mm femoral rod
Utilice el espaciador sólo si utiliza una varilla femoral de 5 mm
Usare il distanziatore solo se si sta usando un’asta femorale
da 5 mm
Distanzstück nur bei Verwendung des 5-mm-Femurstabs
verwenden
Employer un espaceur uniquement si une tige fémorale de
5 mm est utilisée
Gebruik de afstandshouder alleen als u de 5mm dijbeenstang
gebruikt
Use o espaçador somente se usar uma vareta do fémur de 5 mm
Brug kun mellemlæg, hvis der bruges en 5-mm femoralstav
Bruk mellomstykke bare hvis du bruker en 5 mm femoral stav
Käytä välikappaletta vain 5 mm reisitangon kanssa.
Χρησιμοποιήστε τον αποστάτη μόνον αν χρησιμοποιείτε
μηριαία ράβδο 5 mm
Använd avståndsbricka endast om du använder en 5 mm
femoralstång
Rozpěrku využijte pouze při použití 5mm femorálního hřebu.
Medzerník sa používa len s femorálnou tyčou 5 mm
Użyj rozpórki tylko wtedy gdy korzystasz z 5 mm udowego
elementu prowadzącego
Используйте проставку только при использовании 5-мм
бедренного стержня
Csak az 5 mm femorális rúddal együtt használjon távtartót
Aralayıcıyı sadece 5 mm femoral rod kullanıyorsanız kullanın
只有使用5毫米股骨杆时才使用隔套
僅當在使用 5mm 股骨固定桿時使用調整墊
대퇴 막대 사용시에만 스페이서를 사용하십시오

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Figure 4 Figure 4A
Figure 5 Figure 5A
Figure 6 Figure 6A

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Figure 8 Figure 8A
Figure 9 Figure 9A
Figure 7 Figure 7A

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ENGLISH
DePuy Mitek RIGIDFIX® FEMORAL
3.3mm ST CROSS PIN KIT
DESCRIPTION
The DePuy Mitek RIGIDFIX Femoral 3.3mm ST Cross Pins
are absorbable Poly Lactic Acid (PLA) implants used for the
fixation of soft tissue (semitendinosus and gracilis) grafts to
the femur in Anterior Cruciate Ligament (ACL) reconstruction.
The absorption of the pins occurs over a time period greater
than the normal tissue to bone healing time of 12 weeks. Two
DePuy Mitek RIGIDFIX Femoral 3.3mm ST Cross Pins are
used to complete the repair. DePuy Mitek RIGIDFIX Femoral
3.3mm ST Cross Pin Instruments are used to install the
DePuy Mitek RIGIDFIX Femoral 3.3mm ST Cross Pins.
The DePuy Mitek RIGIDFIX Femoral 3.3mm ST Cross Pin Kit
includes two (2) absorbable Cross Pins, two (2) disposable
sleeve assemblies, and one (1) interlocking trocar. The
DePuy Mitek RIGIDFIX Femoral 3.3mm ST Cross Pin
Kit is supplied STERILE. Contents are sterile unless the
package is damaged or opened. Do not re-sterilize.
MATERIALS
Cross Pins: Poly Lactic Acid (PLA)
Sleeve Assemblies, 5mm spacer, and Interlocking
Trocar: Stainless Steel
INDICATIONS
Femoral fixation of autograft or allograft ACL soft tissue
grafts (semitendinosus and gracilis).
CONTRAINDICATIONS
1. Pathological conditions of bone, such as cystic
changes or severe osteopenia, which would
compromise secure cross pin fixation.
2. Pathologic conditions in the soft tissue graft to be
attached which would impair secure fixation with the
cross pins.

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3. Physical conditions which would eliminate, or tend to
eliminate adequate implant support or retard healing:
i.e. blood supply limitations, infection, etc.
4. Conditions which tend to preempt the patient’s ability
to heal during the healing period, such as senility,
mental illness or alcoholism.
PRECAUTIONS
1. A surgeon should not attempt clinical use of DePuy
Mitek RIGIDFIX Femoral 3.3mm ST Cross Pins before
reviewing the instructions for use and rehearsing the
installation procedure in a skills laboratory.
2. Discard used sleeve assemblies and interlocking
trocars in a sharps container.
WARNINGS
1. Poly Lactic Acid (PLA) materials have shown to
cause some tissue reaction in a small percentage
of patients.
2. The DePuy Mitek RIGIDFIX Femoral 3.3mm ST Cross
Pin Kit must never be reused. Do not re-sterilize.
This product is for single-use only. It has not been
designed to be re-used/re-sterilized. Reprocessing
may lead to changes in material characteristics such
as deformation and material degradation which may
compromise device performance. Reprocessing
of single use instruments can also cause cross-
contamination leading to patient infection. These risks
may potentially affect patient safety.
Discard opened and unused RIGIDFIX Femoral Cross
Pins, Sleeve Assemblies and Interlocking Trocar.
INSTRUCTIONS FOR USE – Single Tunnel Repair
1. Harvest and prepare the soft tissue (semitendinosus
and gracilis) graft by folding the graft in half and whip
stitching the looped end of the graft which will be
placed in the femoral tunnel. Use #2 ETHIBOND®
Excel braided polyester suture or #2 ORTHOCORD™
Suture for whip stitching(Figure 1). Using the graft
sizing block, measure the diameter of the graft.
Prepare the tibial and femoral tunnels to be as close
to the diameter of the graft as possible.
2. Attach the appropriate size Femoral Rod (i.e., a 9mm
femoral rod for a 9mm femoral tunnel) to the guide
body and insert the guide over the guide pin into the
femoral tunnel (Figure 2). Remove the guide pin.

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3. Assemble the sleeve over an interlocking trocar
(Figure 3). Drill the sleeve/trocar assembly through
the bottom hole of the guide into the lateral side of the
femur until the sleeve hub meets the guide (Figure 4).
4. Remove the trocar by PULLING it from the sleeve,
leaving the sleeve in the guide/femur. Alternately, the
trocar may be drilled or rotated out in a counter –
clockwise fashion. (Figure 5).
5. Repeat steps 3 and 4, drilling the second sleeve/
trocar assembly through the top hole of the guide
(Figure 6).
6. Place the guide pin back into the femur through the
cannulation of the femoral rod. Detach the guide plate
and remove the guide body from the knee, leaving
only the two sleeves in the femur.
7. Using a guide pin, pull the ST graft into the femoral
tunnel (Figure 7).
8. Insert a DePuy Mitek RIGIDFIX Femoral 3.3mm ST
Cross Pin into the bottom sleeve using the Stepped
Pin Insertion Rod and Mallet. Advance until the
stepped portion of the rod meets the sleeve hub.
9. Using the Sleeve Removal Tool, remove the bottom
sleeve from the femur. Use caution when removing
the sleeve from the femur. Pulling off axis from line of
insertion may cause the sleeve to break in the bone.
10. Repeat steps 8 and 9 in the top sleeve to complete
the repair (Figures 8 & 9).
INSTRUCTIONS FOR USE – Double Tunnel Repair
1. Harvest and prepare the soft tissue (semitendinosus
and gracilis) grafts by folding each graft in half
independently and whip stitching the looped end
of the graft which will be placed in the femoral
tunnel. Use #2 ETHIBOND® Excel braided polyester
suture or #2 ORTHOCORD™ suture for whip
stitching(Figure 1A). Ensure that whip stitching
extends as close to the passing loop as possible.
Using the graft sizing block, measure the diameter of
each graft. Prepare the tibial and femoral tunnels to
be as close to the diameter of each graft as possible.
2. Attach the appropriate size Femoral Rod (i.e., a 6mm
femoral rod for a 6mm femoral tunnel) to the guide
body and insert the guide over the guide pin into the
femoral tunnel (Figure 2).

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If using the 5mm femoral rod, ensure that the rod is
positioned so that the tip opening faces the guide
body. Remove the guide pin.
3. For best accuracy in cross drilling, ensure that the
patients leg remains in a constant position for the
following steps.
4. Assemble the sleeve over an interlocking trocar
(Figure 3). Drill the sleeve/trocar assembly through a
hole of the guide into the lateral side of the femur until
the sleeve hub meets the guide (Figures 4 and 4A).
Note: If using the 5mm Femoral Rod, the Included
Spacer must be used between the Trocar pins &
Sleeve hub as shown in Figure 4A.
5. Remove the trocar by PULLING it from the sleeve,
leaving the sleeve in the guide/femur. Alternately,
the trocar may be drilled or rotated out in a counter -
clockwise fashion. (Figures 5 and 5A).
6. Detach the guide plate and remove the the guide body
from the knee, leaving only the sleeve in the femur.
7. Insert a guide pin through the sleeve (placed in
step 4) extending into the femoral tunnel.
8. Inspect the cross pin hole location using direct
visualization (with the scope) of the guide pin placed
in step 7 to ensure accurate cross pin hole/tunnel
alignment.
9. If alignment is NOT acceptable, remove sleeve and
repeat steps 3 – 8.
10. If using the 5mm femoral rod, at this point drill through
the sleeve using the trocar WITHOUT the spacer to
penetrate the opposite side of the femoral tunnel.
Ensure that the trocar is advanced until the trocar
pins are almost touching the sleeve hub. Take care
not to spin or otherwise disturb the sleeve location.
11. Repeat steps 2 – 10 for the second femoral tunnel
(Figure 6A). Ensure that the second tunnel/sleeve
does not interfere with the first.
12. Place the guide pin back into the first femoral tunnel
and pull the first graft into the first femoral tunnel
(Figure 7A)
13. Place the guide pin back into the second femoral
tunnel and pull the second graft into the second
femoral tunnel (Figure 7A). Ensure that AM and PL
bundles are properly located relative to each other.

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14. Insert a DePuy Mitek RIGIDFIX Femoral 3.3mm ST
Cross Pin into the first sleeve using the Stepped Pin
Insertion Rod and Mallet. Advance until the stepped
portion of the rod meets the sleeve hub. Repeat for
second tunnel. (Figures 8A and 9A)
15. Using the Sleeve Removal Tool, remove the sleeves
from the femur. Use caution when removing the
sleeves from the femur. Pulling off axis from line of
insertion may cause the sleeve to break in the bone.
STORAGE
Store in a cool dry area (below 26°C, 80°F). Sterile
product, once opened, should be used in surgery or
discarded. Never return to storage.
ESPAÑOL
JUEGO DE CLAVO TRANSVERSAL ST
DE 3,3 mm RIGIDFIX® DePuy Mitek
DESCRIPCIÓN
Los clavos transversales ST de 3,3 mm RIGIDFIX DePuy
Mitek son implantes absorbibles poli lactida utilizados
para la fijación de injertos de tejido blando (músculo
semitendinoso y gracilis) al fémur en la reconstrucción
del ligamento cruzado anterior. La absorción de los
clavos tiene lugar después de un período superior al
tiempo normal de cicatrización del tejido al hueso de
12 semanas. La reparación total requiere dos clavos
transversales ST de 3,3 mm RIGIDFIX DePuy Mitek.
Para su colocación, debe utilizarse el Instrumental para
clavo transversal ST de 3,3 mm RIGIDFIX DePuy Mitek.
El juego de clavo transversal ST de 3,3 mm RIGIDFIX
DePuy Mitek incluye dos (2) clavos transversales
absorbibles, dos (2) juegos de camisa desechables y
un (1) trócar de unión. El juego de clavo transversal
ST de 3,3 mm RIGIDFIX DePuy Mitek se suministra
ESTÉRIL. El contenido se encuentra estéril a menos que
el envase esté abierto o dañado. El producto no debe
reesterilizarse.