Johnson & Johnson DePuy Mitek SPIRALOK Manual Del Usuario página 3

Needles: Stainless steel. See package label for type
and size.
INDICATIONS
Shoulder: Rotator cuff repair.
CONTRAINDICATIONS
Surgical procedures other than those listed in the
INDICATIONS section; pathological conditions of bone,
such as cystic changes or severe osteopenia, which
would compromise secure anchor fixation; pathological
conditions in the soft tissue to be attached which
would impair secure fixation by suture; comminuted
bone surface, which would compromise secure anchor
fixation; physical conditions which would eliminate, or
tend to eliminate, adequate implant support or retard
healing, i.e., blood supply limitation, infection; conditions
which tend to preempt the patient's ability to heal or
the healing period, such as senility, mental illness, or
alcoholism; attachment of artificial ligaments or other
implants; reattachment of intracapsular knee ligaments
(ACL & PCL).
INSTRUCTIONS FOR USE
For use arthroscopically, insert the SPIRALOK Delivery
guide and Introducer through the appropriate sized
cannula and place against the bone at the desired
insertion site. Remove the introducer and follow the steps
below. The instruments and the SPIRALOK anchor will fit
through the SPIRALOK delivery guide.
5.0mm 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. In harder bone, the awl may be used first followed by
the tap.
5A. Position the SPIRALOK TAP into the hole
in the bone made by the awl and establish
axial alignment.
5B. 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.
5C. Rotate the tap in a counter-clockwise direction
to remove.
6. Insert the SPIRALOK anchor into the hole created by
the awl while maintaining same axial alignment.
7. Rotate the SPIRALOK inserter handle in a clockwise
direction until the etched depth marking on the handle
2