smith&nephew OSTEORAPTOR Modo De Empleo página 5

Instructions for Use
Use of approved Smith & Nephew instrumentation is
strongly recommended to prepare the insertion site and
maintain axial alignment between insertion site and the
OSTEORAPTOR ™ Suture Anchor.
• When using OSTEORAPTOR 2.3 mm Suture Anchors, use
a Smith & Nephew 2.3 mm in-line drill guide, 2.3 mm
obturator, and a drill bit specific to the suture anchors to
prepare the insertion site (each sold separately).
• When using OSTEORAPTOR 2.9 mm Suture Anchors, use
a Smith & Nephew 2.9 mm in-line drill guide, 2.9 mm
obturator, and a drill bit specific to the suture anchors to
prepare the insertion site (each sold separately).
1. Using the suture anchor size-specific in-line drill guide
and obturator, place the distal tip of the guide onto the
bone at the desired implantation site. In-line drill guide
placement may be achieved using the cannulated or
non-cannulated obturators. Remove the obturator.
2. While firmly holding the in-line drill guide in place, use
the appropriate drill bit for the suture anchor to prepare
the insertion site:
a. The depth stop on the drill bit for the suture anchor
will bottom out on the proximal end of the in-line drill
guide when proper hole depth is reached.
b. The wide viewing window on the in-line guide can be
used to gauge proper hole depth by advancing the
drill bit until the black band on the drill is aligned with
the center of the wide viewing window.
3. While holding the in-line drill guide steady, remove the
drill bit from the insertion site by turning it while backing
the drill bit axially out of the hole.
4. Using routine sterile technique, remove the appropriate
suture anchor with attached insertion device from its
packaging.
5. Establish and maintain axial alignment of the suture
anchor to the drilled insertion site using the in-line drill
guide. Insert the suture anchor with inserter into the
proximal end of the in-line drill guide. Rotate the inserter
to align the suture to the desired position. Next, push
and/or tap the anchor into the site using the insertion
device. Continue pushing and/or tapping the anchor
inserter until recommended insertion depth is achieved.
The laser depth marks will be centered in the in-line
guide's distal windows. This positions the suture anchor
to the appropriate depth below the surface of the bone.
6. Disengage the suture anchor from the inserter:
a. Hold the handle securely in the palm of the hand
and pull back on the finger grips using two fingers
to retract the suture tensioning mechanism.
b. While holding the tensioning mechanism in the back
position with the finger grips, slowly remove the
inserter from the insertion site until the suture tips
are visible. The suture will release and feed through
the inserter as it is removed.
Alternatively:
a. Pull back on the finger grips and unwind the suture
with the free hand, then release the finger grips.
b. Slowly remove the inserter.
c. As the inserter is removed, grasp the suture below the
inserter using the free hand to verify suture release
from the inserter.
CAUTION: Do not use sharp instruments to manage or
control the suture.
7. Discard the insertion device.
Use of Smith & Nephew Drill Bits
for OSTEORAPTOR Suture Anchors
(sold separately)
Smith & Nephew drill bits should be used with the
OSTEORAPTOR Suture Anchors to aid in the preparation
of the insertion site.
• The surgeon should select the means of drilling
(e.g., power drill, manual drill, etc.). Proper hole
depth can be achieved by the following:
– Recommended: The depth stop on the drill bit will
bottom out on the proximal end of the in-line drill
guide when proper hole depth is reached.
– The wide viewing window on the in-line guide can
be used to gauge proper hole depth by advancing
the drill bit until the black band in the drill is centered
within the wide viewing window.
– If an in-line drill guide is not used, proper hole depth
can be achieved when the shoulder on the distal end
of the drill bit contacts the bone surface.
Note: Use of a Smith & Nephew in-line drill guide and
obturator is strongly recommended to aid in the preparation
of the insertion site for all hip procedures.
WARNING: Inspect the drill bit for damage prior to
use. Replace a damaged or worn drill bit. Do not
attempt to straighten or sharpen the drill bit. Sharpening
will alter the implantation site and could affect anchor
stability.
OSTEORAPTOR™ Suture Anchor
Instructions for Use
English
10600388 Rev. E
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