Adverse Reactions - smith&nephew OSTEORAPTOR Modo De Empleo

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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.
• 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.
• 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 OSTEORAPTOR™
Suture Anchor 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 OSTEORAPTOR 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 OSTEORAPTOR
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 OSTEORAPTOR Suture Anchor
requires preparation of the insertion site. Pre-drilling with
the appropriate Smith & Nephew Drill Bit is the preferred
method of site preparation.
• 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

• Loss of fixation or pullout of suture anchors can occur
• Mild inflammatory reaction
• Foreign body reaction
• Infection, both deep and superficial
• Allergic reaction
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10600388 Rev. E
OSTEORAPTOR™ Suture Anchor
Instructions for Use