6
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.
Содержание DePuy Mitek Rigidfix 104144
Страница 2: ...1 Figure 1 Figure 1A Figure 2 PROCEDURE INSTRUCTIONS...
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Страница 78: ...77 RIGIDFIX 1 ETHIBOND Excel 2 ORTHOCORD 2 1 2 9 9 2 3 3 4 4 5 5 3 4 6 6...
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