Contraindications - Smith & Nephew BIORAPTOR Mode D'emploi

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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.
• Product must be stored in the original
sealed pouch.
• Product should be stored at ambient
temperature. Prolonged exposure of
absorbable anchors to elevated temperatures
may lead to degradation of the anchor.
• Product exposed to temperature below
ambient for an extended time period must be
allowed to return to room temperature prior
to use. Failure to do so may result in reduced
mechanical performance of the product.
• 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.
• Incomplete anchor insertion may result in poor
anchor performance.
• Breakage of the suture anchor can occur if
the insertion site is not prepared with the
recommended Smith & Nephew drill prior to
implantation.
• Associated instruments for the BIORAPTOR™
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 drill bits and drill
guides intended for use with the BIORAPTOR
Suture Anchor or the implant may not be
properly aligned.
• 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.
• Do not attempt to implant this device within
cartilage epiphyseal growth plates or non-
osseous tissue.
• Do not resterilize or reuse anchors, sutures
and insertion devices packaged with the
BIORAPTOR Suture Anchor.
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.
• Postoperative care is important. A patient should
be instructed on the limitations of the implant and
should be cautioned regarding weight bearing and
body stresses on the appliance prior to secure
bone healing.
• 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 Suture Anchor
requires preparation of the insertion site.
Pre-drilling with the appropriate Smith & Nephew
BIORAPTOR Drill Bit is the preferred method of site
preparation.
4
10600304 Rev. B
BIORAPTOR™ Suture Anchor
Instructions for Use