Johnson & Johnson DePuy Synthes HEALIX PEEK Manual Del Usuario página 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.
6 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 deformation and material degradation which may
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. 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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