Adverse Reactions - Smith & Nephew BIORAPTOR 2,3 PK Mode D'emploi

English
Precautions
U.S. Federal law restricts this device to
sale by or on the order of a physician.
• Hazards associated with reuse of this
device include, but are not limited to,
patient infection and/or device malfunction.
• Prior to use, inspect the device to ensure
it is not damaged. Do not use a damaged
device.
• Do not use sharp instruments to manage
or control the suture.
• As in all suture anchor or suturing
techniques, the fixation given should
be considered as only temporary, until
biological attachment of tissue to bone is
completed, and may not withstand weight
bearing or other unsupported stresses. The
suture anchor and suture are not intended
to provide indefinite biomechanical integrity.
• Implantation of the BIORAPTOR Curved
2.3 PK Suture Anchor requires preparation
of the insertion site. Pre-drilling with the
appropriate Smith & Nephew flexible
drill bit is the required method of site
preparation.
• 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 BIORAPTOR™
Curved 2.3 PK Suture Anchors.
When using a BIORAPTOR Curved 2.3 PK
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.
4
10600702 Rev. C
BIORAPTOR™ Curved 2.3 PK
Suture Anchors
Instructions for Use