Adverse Reactions - smith&nephew FOOTPRINT Ultra PK Mode D'emploi

English
• Do not remove the retention suture from the inserter
before the anchor is properly secured in the insertion
site. The retention suture can be used to retrieve the
anchor should it disengage prior to being inserted
into the bone.
• Rotate the torque limiter counterclockwise only
enough to allow the sutures to slide easily. Excessive
counterclockwise rotation can unscrew the inner
anchor plug from the anchor implant, possibly
resulting in a damaged anchor or the inner plug
falling off the inserter and into the joint.
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.
• 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.
• Bone must be adequate to allow proper placement
of suture anchor.
• Users should not alter implant or instrumentation
or 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

• Breakage of the suture can occur
• Loss of fixation or pullout of suture anchors can occur
• Mild inflammatory reaction
• Foreign body reaction
• Infection, both deep and superficial
• Allergic reaction
Instructions for Use
The use of approved Smith & Nephew surgical
instrumentation is strongly recommended to prepare the
insertion site and maintain axial alignment between the
insertion site and the FOOTPRINT Ultra PK Suture Anchor.
1. Using routine sterile technique, remove the suture
anchor from the packaging.
Note: The torque limiter located at the proximal end of
the handle is preset and should not be turned until the
anchor has been fully seated and proper tension has
been applied to the suture.
2. Use the appropriate Smith & Nephew hole preparation
device to prepare the insertion site.
• Smith & Nephew disposable and reusable awls
specific to the suture anchor are sold separately.
• When a larger hole is required, as in the case of
hard bone, reusable drills specific to the suture
anchor are sold separately.
• Refer to table below for recommended hole
preparation device.
Suture
Anchor
FOOTPRINT
Ultra PK
4.5 mm
FOOTPRINT
Ultra PK
5.5 mm
3. Place the distal tip of the awl/drill onto the bone at the
desired implantation site.
4. Hold the awl in place and use a mallet to tap the
proximal end to prepare the insertion site. The proper
hole depth is achieved when the laser depth mark or
circular groove on the distal end of the awl contacts the
bone surface.
Optional: Place the distal tip of the spade drill onto
the bone at the desired implantation site. Advance the
spade drill until the shoulder on the drill bit reaches the
bone surface.
5. Hold the awl/drill in axial alignment and remove the
awl/drill from the insertion site. The distal surface of the
awl handle can be tapped with a mallet to facilitate the
removal.
4
10600584 Rev. D
For Soft Bone
REF
72202621,
3.8 mm
Tapered Awl,
Disposable
REF
72201915,
3.8 mm
Tapered Awl,
Reusable
For General
Use
REF
72202986,
3.8 mm
Straight Awl,
Disposable
REF
72201450,
3.8 mm
Straight Awl,
Reusable
FOOTPRINT Ultra PK Suture Anchor
For Hard
Bone
REF
72202116,
3.5 mm
Spade Tip
Drill
REF
72201707,
4.5 mm
Spade Tip
Drill
Instructions for Use