Johnson & Johnson DePuy Mitek HEALIX PEEK Mode D'emploi page 4

WARNINGS
1. DePuy Mitek anchors are designed to lock into
cortical or cancellous bone. Bone stock must
be adequate to allow proper and secure anchor
placement. Incomplete insertion or poor bone quality
may result in anchor pullout.
2. Immediate range of motion should be avoided to allow
biological bony/soft tissue healing.
3. This device is not approved for screw attachment or
fixation to the posterior elements (pedicles) of the
thoracic or lumbar spine.
4. As a braided suture, which is essentially absorbed
over 1.5 to 2.5 years, the PANACRYL suture may act
as a foreign body over an extended period of time.
The surgeon should consider whether use of an
absorbable suture is appropriate in specific situations
such as in wounds that carry an increased risk of
infection or contamination.
5. Users should be familiar with surgical procedures and
techniques involving absorbable and non-absorbable
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.
INSTRUCTIONS FOR USE
1. Position the awl on the prepared bone surface and
establish the proper axial alignment.
2. Using a mallet, tap the awl into the bone until the
appropriate etched depth marking is flush with the
bone surface. (Distal marking for the 4.5mm anchor,
Proximal marking for the 5.5mm and 6.5mm anchor)
3. Grasp the handle of the awl firmly and remove it
from the bone by pulling at the same axial angle of
insertion. Set the awl aside for next anchor insertion.
4. In harder bone, the awl may be used first followed by
the appropriate tap.
4A. Position the appropriate tap into the hole in
the bone made by the awl and establish axial
alignment.
4B. Rotate the tap in a clockwise direction until the
etched depth marking is flush with the bone.
4C. Rotate the tap in a counter-clockwise direction to
remove.
5. Insert the HEALIX PEEK anchor into the hole
created by the awl while maintaining the same axial
alignment.
6. Rotate the HEALIX PEEK inserter handle in a
clockwise direction until the etched depth marking on
the handle shaft is flush with the bone.
7. Open slide cover on the inserter handle and remove
suture card.
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