Adverse Reactions - smith&nephew OSTEORAPTOR Curved Modo De Empleo

• Ensure the anchor placement is aligned
with the drilled hole. Proper alignment
is essential for successful anchor
implantation.
• Use of excessive force and/or misalignment
during insertion can cause failure of the
suture anchor and/or flexible insertion
device.
• Bone quality must be adequate to allow
proper placement of suture anchor.
• Do not alter implant or instrumentation
or performance may be compromised.
• 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 required to prepare the
insertion site and maintain axial alignment
between insertion site and the OSTEORAPTOR
Curved 2.3 Suture Anchors.
When using a OSTEORAPTOR Curved 2.3
Suture Anchor, use a Smith & Nephew curved
guide, flexible obturator, and flexible drill bit
specific to the suture anchor to prepare the
insertion site (each sold separately).
1. Using the Smith & Nephew curved guide
and flexible obturator, place the distal tip
of the curved guide onto the bone at the
desired implantation site. Remove the
obturator.
2. While firmly holding the curved guide in
place, use the Smith & Nephew flexible
drill bit to prepare the insertion site:
Note: It is recommended to drill in one
continuous motion to prepare the site.
Note: The depth stop on the drill bit for the
suture anchor bottoms out on the proximal
end of the curved guide when proper hole
depth is reached.
3. Maintain alignment while holding the
curved guide steady and remove the drill
bit from the insertion site with the drill bit
rotating in the forward direction.
4. Using routine sterile technique, remove
the suture anchor with attached insertion
device from its packaging.
5. Holding the curved guide firmly in place,
insert the preloaded suture anchor with the
suture channel aligned with the laser mark
on the handle of the curved guide (Figure 1).
Figure 1
6. Push and/or tap on the proximal end of
the insertion device to insert the anchor.
Proper insertion depth is achieved when
the insertion device handle makes contact
with the proximal end of the guide handle.
This positions the suture anchor at the
appropriate depth below the surface of
the bone.
OSTEORAPTOR™ Curved 2.3
Suture Anchors
Instructions for Use
10600890 Rev. C
English
5