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Les langues disponibles
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Pathological conditions of bone, such as cystic
changes or severe osteopenia, which would
compromise secure anchor fixation.
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Pathological conditions in the soft tissues to
be attached that would impair secure fixation
by suture.
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Comminuted bone surface, which would compromise
secure anchor fixation.
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Physical conditions, which would eliminate, or
tend to eliminate, adequate anchor support or retard
healing, i.e., limitation of blood supply, infection, etc.
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Conditions which tend to preempt the patient's ability
to heal or the healing period, such as senility, mental
illness, or alcoholism.
Warnings
Do not use if package is damaged. Do not use if
the product sterilization barrier or its packaging
is compromised.
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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.
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Product must be stored in the original sealed
foil pouch.
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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.
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The TWINFIX™ 6.5 AB anchor is not recommended
for use in hard bone.
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Incomplete anchor insertion may result in
poor anchor performance.
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Breakage of the suture anchor can occur
if insertion sites are not prepared with
threaded dilator prior to implantation.
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Do not attempt to implant this device
within cartilage epiphyseal growth plates
or non-osseous tissue.
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Do not resterilize or reuse anchors, sutures,
insertion devices, threaded dilators or guides.
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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.
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.
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Prior to use, examine the device(s) for possible
damage to assure proper functioning. If damaged,
do not use.
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A surgeon should not attempt clinical use of
TWINFIX AB Preloaded Suture Anchors before
reviewing these Instructions for Use.
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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.
•
Excessive force during insertion can cause failure of
the suture anchor or insertion device. A two-finger
AO technique should be used to insert the anchor.
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Bone must be adequate to allow proper placement
of suture anchor.
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Users shall not alter implant or instrumentation,
otherwise performance may be compromised.
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Postoperative range of motion is to be determined
by the physician.
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Do not use sharp instruments to manage or control
the suture.
Adverse Effects
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Breakage of the suture can occur.
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Loss of fixation or pullout of suture anchors can occur.
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Mild inflammatory reaction.
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Foreign body reaction.
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Infection, both deep and superficial.
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Allergic reaction.
TWINFIX™ AB Preloaded
Suture Anchors
Instructions for Use
English
10600148 Rev. B
3
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