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MRI STATEMENT
• PEEK and BR Anchor:
The PEEK and BR Anchors have not been evaluated
for safety and compatibility in the MR environment.
They have not been tested for heating or migration
in the MR environment.
• Titanium Anchor:
• Non-clinical testing has demonstrated that DePuy
Mitek titanium suture anchors are MR Conditional.
A patient with a DePuy Mitek titanium suture
anchor can be scanned safely under a static
magnetic field of 1.5 or 3.0 Tesla.
• Artifact information: MR Image quality may be
compromised if the area of interest is in the exact
same area or relatively close to the position of the
DePuy Mitek titanium suture anchor. Therefore,
optimization of MR imaging parameters to
compensate for the presence of this device may
be necessary.
INSTRUCTIONS FOR USE
For the PEEK and BR Anchors:
1. Position the appropriate awl/tap onto the prepared
bone surface. Establish the proper axial alignment.
2. Using a mallet, impact the awl/tap into the bone
until the smaller threads located at the distal tip
have been inserted into bone and the first larger
thread is flush with bone. Rotate the awl/tap in a
clockwise direction until the distal laser line is flush
with the bone. Rotate the awl/tap in a counter-
clockwise direction to remove.
3. Insert the PEEK or BR anchor into the hole
created by the awl/tap while maintaining the same
axial alignment.
4. Rotate the inserter handle of the anchor in a
clockwise direction until the distal laser line on the
anchor inserter shaft is flush with the bone.
5. Open the slide cover on the inserter handle and
remove suture card.
6. Remove inserter from anchor by pulling straight
back on handle.
7. Apply tension (normal force) on suture lengths.
EXCESSIVE FORCE MAY OVERLOAD THE
ANCHOR OR SUTURE.
8. Use the suture provided for soft tissue fixation.
For the Titanium Anchor:
1. Position the Ti anchor onto the prepared bone
surface. Establish the proper axial alignment.
4
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