smith&nephew OSTEORAPTOR Curved Modo De Empleo página 4

English
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 OSTEORAPTOR™ 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
OSTEORAPTOR 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 breakage.
• Do not attempt to implant this device
into non-osseous tissue.
• Do not resterilize or reuse anchors,
sutures, and flexible insertion devices
packaged with the OSTEORAPTOR
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.
• Breakage of the suture anchor can occur
on insertion if the suture channel is not
properly aligned with the laser mark on
the handle of the curved guide.
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. The suture anchor and suture
are not intended to provide indefinite
biomechanical integrity.
• Implantation of the OSTEORAPTOR™ Curved
2.3 Suture Anchor requires preparation
of the insertion site. Pre-drilling with the
appropriate Smith & Nephew flexible drill
bit while using the Smith & Nephew curved
guides is the required method of site
preparation.
4
10600890 Rev. C
OSTEORAPTOR™ Curved 2.3
Suture Anchors
Instructions for Use