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4. Users should be familiar with surgical procedures
and techniques involving absorbable and
nonabsorbable suture before employing
ORTHOCORD suture for wound closure, as risk
of wound dehiscence may vary with the site of
application and the suture material used.
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 metallic corrosion and dulled edges, and
plastic deformation which may impact the strength
of the device and compromise device performance.
Reprocessing of single use devices can also cause
cross-contamination leading to patient infection.
These risks may potentially affect patient safety.
INSTRUCTIONS FOR USE
1. Remove the suture card and VERSALOK anchor
from the sterile package and remove the suture
from the card.
2. Pass the suture through soft tissue with the
surgeon's preferred suture-passing technique.
3. Check to be sure the suture is not twisted. Load
the suture onto the anchor using the attached
threader tab. The threader tab pulls the suture
strands through the anchor.
4. While keeping nominal tension on the suture
strands, place the shaft against bone at the
selected fixation site and confirm that the suture
is not twisted. If the suture is twisted, untwist the
suture.
5. Tap the back end of the shaft with a mallet,
driving the anchor into bone. Continue tapping
until contact with the distal edge of the laser
line, which is directly before the shoulder of the
pusher is in contact with the bone surface. In hard
bone, the awl may be used first to create a starter
hole. Optional: place the end cap on the shaft to
increase the surface area for the mallet to strike.
6. Remove the end cap, if used, and advance the
Gun (Catalog No. 214710) down the shaft until it
clicks firmly into place.
7. Approximate the repair by pulling on the suture
while placing gently forward pressure on the gun.
The suture may be placed on the tension wheel
on the VERSALOK Gun to hold the tension once
it is manually set or to aide in suture tensioning.
To load the suture on the tension wheel gently
and equally tension the suture strands. Wrap
them around the tension wheel once in a
clockwise direction and then give a quick tug on
the suture to set them into the tension wheel.
Rotate the tension wheel clockwise to tension
the suture. A maximum of two strands can be
tensioned on the wheel at the same time.
5
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