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Instructions for Use
1.
Using routine sterile technique, remove the
TWINFIX™ AB Preloaded Suture Anchor with
attached insertion device, guide, and threaded
dilator from their packaging.
2. Place the distal tip of the guide onto the bone
at the desired implantation site.
3. While the guide is stabilized over the insertion site,
use the threaded dilator to prepare the insertion site.
Turn the threaded dilator clockwise in an axial fashion
until the indicator line on the threaded dilator reaches
the bone surface.
Note: When using the TWINFIX 6.5 AB anchor, it is
recommended to use the 5.0 dilator supplied with
the anchor for most bone types. The TWINFIX 6.5 AB
anchor is not recommended for use in hard bone. If a
larger dilator is needed, a 6.5 dilator can be purchased
separately.
4. Remove the threaded dilator from the insertion site
by turning it counterclockwise.
5. Establish axial alignment of the absorbable suture
anchor to the dilated insertion site. While supporting
the insertion site, rotate the anchor clockwise into the
site using the insertion device. Continue rotating the
anchor until the anchor reaches the bottom of the site,
or until the first indicator line on the insertion device
reaches the bone surface.
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 anchor threads are properly
aligned in the dilated hole. To check alignment of the
threads, rotate the suture anchor counterclockwise.
When all the threads are out of the bone, continue
rotating the suture anchor counterclockwise three-
quarters of a turn. Next, use a clockwise rotation to
reimplant the anchor.
6. 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.
Note: Do not use any metallic or sharp devices to
grasp the suture.
7. Discard insertion device, guide, and threaded dilator.
Instructions for Reassembly
If circumstances necessitate reassembling the suture and
anchor to the insertion device, such as surgeon preference
for alternate suture with the anchor, or partial deployment
of the anchor prior to insertion, reassemble as follows:
1.
Disassemble the suture anchor from the insertion
device:
•
While retracting the suture tensioning mechanism
using the finger grips, gently pull the anchor and
suture from the inserter shaft.
2. Remove the suture from the anchor:
•
Gently pull the suture through the anchor eyelets.
Note: Suture removal is only necessary if an alternate
suture is required.
3. Affix the desired alternate suture to the anchor:
•
Feed 36" minimum length of suture(s) through
the anchor eyelet(s).
•
Equalize the length of each suture leg.
4. Assemble suture anchor into the inserter:
•
Feed the suture(s) into the tip of the inserter
shaft using a 12" suture passer until the suture
tips extend through the handle.
•
Pull the suture through the handle until the
anchor is near the tip of the inserter shaft.
•
Align the anchor eyelets to the axial lines on the
tip of the inserter shaft and seat the anchor into
the tip.
5. Set the suture tension:
•
Wrap the suture around the suture posts on the
handle until the length of the suture tail is equal
to the handle length plus 1/2".
•
Retract the suture tensioning mechanism
using the finger grips.
•
Slide the suture tails into the suture groove
on the handle.
•
Release the finger grips to set the suture tension.
The device is now ready to use.
4
10600148 Rev. B
TWINFIX™ AB Preloaded
Suture Anchors
Instructions for Use
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