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CAUTION: Use of excessive force during insertion can
cause failure of the suture anchor or insertion device.
A two-finger AO technique should be used to insert the
anchor.
If more torque is required to insert the anchor, stop
and ensure that the hole size and depth are correct for
the bone conditions encountered. It may be necessary
to reduce the anchor size or increase the hole size to
achieve optimal insertion force. It is the responsibility of
the surgeon to determine the patient's bone condition,
appropriately prepare the insertion site, and determine
the suitability of the implant for the procedure.
3. Disengage the suture anchor from the inserter:
•
Hold the handle securely in the palm and pull back
on the finger grips with two fingers to retract the
suture tensioning mechanism.
•
While holding the tensioning mechanism in the back
position with the finger grips, slowly remove the
inserter from the insertion site until the suture tips
are visible. The suture will release and feed through
the inserter as it is removed.
Alternatively:
•
Pull back on the finger grips and unwind the suture
with the free hand.
•
Slowly remove the inserter.
•
As the inserter is removed, pinch the suture below
the inserter using the free hand to verify suture
release from the inserter.
CAUTION: Do not use sharp instruments to manage or
control the suture.
4. Discard insertion device.
5. If it becomes necessary to remove the anchor from the
implant site, reengage the anchor head completely
with the insertion device and rotate the anchor in a
counterclockwise direction. If the suture is still attached,
it can be pulled through the insertion device shaft using
a suture passer. This will provide counterforce to the
anchor.
Warranty
For single use only. This product is warranted to be free
from defects in material and workmanship. Do not reuse.
For Further Information
If further information on this product is needed,
please contact Smith & Nephew Customer Service
at +1-800-343-5717 in the U.S., or your authorized
representative.
™Trademark of Smith & Nephew, registered U.S. Patent
and Trademark Office.
©2009, 2010 Smith & Nephew, Inc. All rights reserved.
TWINFIX™ Ultra Ti Preloaded Suture Anchors
Instructions for Use
English
10600538 Rev. B
5
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