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

Knee
• Extra-capsular repairs
– Medial collateral ligament
– Lateral collateral ligament
– Posterior oblique ligament
• Patellar realignment and tendon repairs
– Vastus medialis obliquous advancement
• Iliotibial band tenodesis

Contraindications

• Known hypersensitivity to the implant
material. Where material sensitivity is
suspected, appropriate tests should be
made and sensitivity ruled out prior to
implantation.
• Pathological conditions of bone, such as
cystic changes or severe osteopenia, which
would compromise secure anchor fixation.
• Pathological conditions in the soft tissues
to be attached that would impair secure
fixation by suture.
• Comminuted bone surface, which would
compromise secure anchor fixation.
• Physical conditions which would eliminate,
or tend to eliminate, adequate anchor
support or retard healing.
Warnings
Do not use if package is damaged.
Do not use if the product sterilization
barrier or its packaging is compromised.
• Contents are sterile unless package
is opened or damaged. DO NOT
RESTERILIZE. For single use only. Discard
any open, unused product. Do not use
after the expiration date.
• It is the surgeon's responsibility to be
familiar with the appropriate surgical
techniques prior to use of this device.
• Read these instructions completely prior
to use.
• Product must be stored in the original
sealed pouch.
• Curved guides and flexible obturators
for the BIORAPTOR™ Curved 2.3 Suture
Anchors are sold separately and are
provided non-sterile. These instruments
must be properly cleaned and sterilized
prior to use.
• Only use the appropriate flexible drill
bits, flexible obturators, and curved
guides intended for use with the
BIORAPTOR Curved 2.3 Suture Anchors.
Use of other instruments may injure
the patient, damage the instruments,
or compromise the fixation. Refer to
REF 10600778 Instructions for Use.
• To avoid possible bone fragmentation,
ensure the anchor insertion site is
positioned within sufficient bone stock.
• Maintaining guide alignment throughout
drilling is required to ensure drill bit
integrity.
• Sudden starting and stopping of the
drill bit in the bone may cause drill bit
breakage.
• Do not attempt to implant this device
within cartilage epiphyseal growth
plates or non-osseous tissue.
• Do not resterilize or reuse anchors,
sutures, and flexible insertion devices
packaged with the BIORAPTOR Curved
2.3 Suture Anchors.
• Incomplete anchor insertion may result
in poor anchor performance.
• Breakage of the suture anchor can occur
if insertion sites are not prepared with
appropriate instrumentation prior to
implantation.
BIORAPTOR ™ Curved 2.3 PK
Suture Anchors
Instructions for Use
English
10600702 Rev. C
3