Johnson & Johnson DePuy Synthes GRYPHON, Руководство пользователя

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• While applying half hitch knots, suture may break
at the half hitch knot or adjacent to knot pusher. If
suture breaks at half hitch knot, the post-operative
knot security may be compromised.
PRECAUTIONS
• Use of this product is limited to physicians with a
thorough understanding of orthopaedic procedures
and arthroscopic techniques.
•
Do not resterilize. Do not use if sterile packaging
appears to be damaged.
• Store product in cool, dry conditions.
•
Do not begin clinical use of the GRYPHON Anchor
with PROKNOT Technology without reviewing the
Instructions for Use and practicing the procedure in
a skills laboratory.
• Axial misalignment or levering with the anchor upon
insertion, may result in anchor or inserter fracture.
•
Remove the pre-tied sliding knot (suture loop) from
the suture card by using the free limb as described
in this document; otherwise, the knot may close
prematurely and prevent proper closing around the
free limb.
• After applying one or more half-hitch knots, do not
trim the suture tails/ears to less than 2mm. As with
any knot construct, short tails may result in reduced
post-operative knot security.
ADVERSE EFFECTS
Adverse effects of absorbable implanted devices
include mild inflammatory and foreign body reactions.
MRI STATEMENT
The GRYPHON Anchor with PROKNOT Technology
is MR Safe.
INSTRUCTIONS FOR USE
1. Select instruments of appropriate length for the
intended repair site.
2. Place the distal tip of the drill guide onto the bone
at the desired implantation site. While holding
the drill guide in place, insert the drill bit into the
guide. Using the drill bit, drill hole in bone until
the depth stop at the proximal end of the drill bit
engages (“bottoms out”) onto the proximal end of
the drill guide.
3. Remove the GRYPHON Anchor with PROKNOT
Technology from its package using standard
sterile techniques.
4. Maintaining axial alignment of the drill guide to
the hole, pass the device through the drill guide
cannulation. Insert the anchor into the hole