• Ensure the anchor placement is aligned with the
drilled hole. Proper alignment is essential for
successful repair.
• Use of excessive force during insertion can cause
failure of the suture anchor or insertion device.
• Bone quality must be adequate to allow proper
placement of the suture anchor.
• Do not alter the implant or instrumentation,
otherwise performance may be compromised.
• Postoperative range of motion is to be determined
by the physician.
• After use, this device may be a potential biohazard
and should be handled in accordance with
accepted medical practice and applicable local
and national requirements.
Adverse Reactions
• Breakage of the suture can occur
• Loss of fixation or pullout of suture anchors
can occur
• Mild inflammatory reaction
• Foreign body reaction
• Infection, both deep and superficial
• Allergic reaction
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 BIORAPTOR™ Suture Anchor.
• When using BIORAPTOR 2.3 mm Suture Anchors,
use a Smith & Nephew 2.3 mm 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 BIORAPTOR 2.9 mm Suture Anchors,
use a Smith & Nephew 2.9 mm 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 BIORAPTOR Suture Anchor size-specific
Smith & Nephew 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 drill guide in place,
use the appropriate Smith & Nephew Drill Bit
for the BIORAPTOR 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 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 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.
BIORAPTOR™ Suture Anchor
Instructions for Use
English
10600304 Rev. B
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