Johnson & Johnson DePuy Mitek SPIRALOK Manual Del Usuario página 4

is flush with the bone. The four longitudinal lines at
the distal end of the inserter indicate the position of
the suture limbs as they are positioned through the
anchor's dual suture eyelets.
8. Release the suture card from the inserter handle and
pull inserter away from anchor.
9. Apply tension (nominal force) on suture lengths.
EXCESSIVE TENSION MAY OVERLOAD THE
ANCHOR OR SUTURE.
10. Use the two sutures provided for soft tissue fixation.
6.5mm SPIRALOK
1. Minimum space between each anchor is 5mm.
2. Position the awl on the prepared bone surface and
establish the proper axial alignment.
3. Using a mallet, tap the awl into the bone until the
etched depth marking is flush with the bone surface.
4. Grasp the handle of the awl firmly and remove it
from the bone by pulling at the same axial angle of
insertion. Set the awl aside for next anchor insertion.
5. Position the SPIRALOK TAP into the hole in the bone
made by the awl and establish axial alignment.
6. Rotate the tap in a clockwise direction until the etched
depth marking is flush with the bone. The tap may be
rotated up to one additional turn (3-4 mm) past the
etched depth marking.
7. Rotate the tap in a counter-clockwise direction
to remove.
8. Insert the SPIRALOK anchor into the hole created
by the awl and tap while maintaining same
axial alignment.
9. Rotate the SPIRALOK inserter handle in a clockwise
direction until the etched depth marking on the handle
is flush with the bone. The four longitudinal lines at
the distal end of the inserter indicate the position of
the suture limbs as they are positioned through the
anchor's dual suture eyelets.
10. Release the suture card from the inserter handle and
pull inserter away from anchor.
11. Apply tension (nominal force) on suture lengths.
EXCESSIVE TENSION MAY OVERLOAD THE
ANCHOR OR SUTURE.
12. Use the two sutures provided for soft tissue fixation.
WARNINGS
1. DePuy Mitek anchors are designed to lock into
cortical or cancellous bone. Bone stock must
be adequate to allow proper and secure anchor
placement. Incomplete insertion or poor bone quality
may result in anchor pullout.
2. Anchor may break or fracture if the bone quality is too
hard or dense.
3. Immediate range of motion should be avoided to
allow biological bony/soft tissue healing.
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