6. Select the appropriate limb(s) of suture(s) from either
the implanted suture anchor or the sutures threaded
through tissue. Thread the free ends through the suture
threading loop, remove the suture threader from the
shaft of the insertion device, and pull to feed the sutures
through the anchor.
WARNING: 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.
7. Slide the loaded suture anchor either percutaneously or
through a cannula, depending on technique preference.
Minimize suture entanglement by removing excess
suture slack and advance the anchor to the prepared
bone site. If desired, secure the free ends of the suture
using the features located on the inserter handle. Do not
attempt to tension the suture(s) at this time.
8. Orient the anchor such that the free limb sutures
entering the anchor are facing the tissues and the
sutures are not twisted around the anchor.
9. Establish and maintain axial alignment of the suture
anchor to the prepared insertion site, and place
the tip of the anchor into the prepared hole. Use
the Smith & Nephew mallet (sold separately) to tap
the inserter handle until the laser mark is flush with
the cortical bone. This places the suture anchor
approximately 1 mm below the bone surface.
10. Unhook the retention suture from the inserter handle
and pull one end to remove the suture from the handle.
Discard the retention suture. The retention suture must
be removed prior to applying tension.
11. Apply tension and lock the suture.
WARNING: 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.
a) Maintain slight downward pressure on the inserter
handle and remove the free ends of the suture(s)
from the inserter handle. Manually pull suture(s)
(individually or together) to apply the desired tension.
b) If desired, secure the free ends of the suture using
the features located on the inserter handle. Maintain
slight downward pressure on the inserter, locate the
knob on the proximal end of the inserter handle and
rotate it clockwise. Continue rotating the knob until a
click is heard.
c) Check the final repair. If the final tension on
the suture is not adequate, rotate the knob
counterclockwise until the suture can slide easily.
Repeat steps "a" and "b" to apply appropriate tension
and lock the suture. Repeat as necessary to achieve
the desired repair.
d) Prior to removing the inserter, rotate the torque
limiter knob counterclockwise one quarter turn, until
a click is heard. This will help ease the release of the
inserter from the anchor.
12. Slowly disengage the suture anchor from the inserter
by pulling straight back or tapping the distal end with
a mallet. Do not wiggle the handle to disengage the
anchor. Discard the insertion device and cut the excess
suture.
Warranty
For single use only. This product is warranted to be free from
defects in material and workmanship. Do not reuse.
For Further Information
If further information on this product is needed, contact
Smith & Nephew Customer Service at +1 800 343 5717
in the U.S., or an authorized representative.
All trademarks acknowledged.
©2009, 2011 Smith & Nephew, Inc. All rights reserved.
FOOTPRINT Ultra PK Suture Anchor
Instructions for Use
English
10600584 Rev. D
5