Johnson & Johnson DePuy Synthes GRYPHON, Manual

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• Pathologic changes in the soft tissues that would
prevent secure tissue-to-bone fixation by the anchor
•
Comminuted bone surface that would prevent or
interfere with secure fixation of the anchor
• Physical conditions that would eliminate, or tend to
eliminate adequate implant support or retard healing
(e.g., blood supply limitation, previous infection, etc.)
•
Conditions that would tend to limit the patient’s
ability to restrict activities or follow directions during
the healing period
• The GRYPHON Anchor with PROKNOT Technology
is not designed for, and should never be used for
attaching artificial ligaments.
WARNINGS
• 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 pull-out.
•
Avoid immediate range of motion to allow biological
bony/soft tissue healing.
• This device is not approved for screw attachment or
fixation to the posterior elements (pedicles) of the
thoracic or lumbar spine.
•
Users should be familiar with surgical procedures
and techniques involving non-absorbable suture
before employing PERMACORD 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 deformation and material degradation, which
may compromise device performance. Reprocessing
of single use instruments can also cause cross-
contamination leading to patient infection. These
risks may potentially affect patient safety.
•
After disengaging the pre-tied sliding knot from the
suture card, confirm that the loop/knot is fully closed
around the free limb. A loosely closed loop/knot may
compromise post-operative knot security.
• To ensure adequate post-operative knot security,
fully seat half hitch knots against the pre-tied
sliding knot or any previous half hitch knots. Suture
twists may inhibit the seating of the half hitches.
If knot security of first half hitch cannot be visually
confirmed, apply additional half hitch knots.
•
If soft tissue is captured between the half hitch knot
and the pre-tied sliding knot, the post-operative knot
security may be compromised. If knot security of
first half hitch cannot be visually confirmed, apply
additional half hitch knots.