Directions For Use - Neoligaments Fastlok 102-1380 Instrucciones De Uso

Directions for Use

Users of this device are encouraged to contact the
Neoligaments Sales Department if, in their professional
judgement, they require a more comprehensive
surgical technique.
Impacting the Fastlok into Bone
See images at the front of this booklet.
Figure 1
Push the staple firmly into the Impactor. Thread the
free end of the ligament (1a) through the buckle which
must be held with forceps at the middle of its free long
side (forceps not shown). Hold the Impactor above the
buckle so that the legs of the staple are parallel with
the buckle.
Figure 2
Bring the staple down past the side of the buckle over
which the ligament is folded, so that the legs of the
staple straddle the folded ligament. Turn the staple
(Impactor) through 90º in the horizontal plane.
Figure 3
The buckle is then flipped down through 180º over the
staple. Check that the staple legs still straddle both of
the ligament layers. This last step must be performed
carefully and it is vital that as the staple is turned it
does not pierce the ligament.
Figure 4
Ensure that the ligament is not trapped between the
buckle and staple. Simultaneously pull on the ligament
end (4a) while pushing the staple (Impactor) along
the ligament (4b), forwards toward the chosen site
for implanting the Fastlok. During this step do not
straighten the ligament. Its two ends must be at the
angle shown, otherwise it may be difficult to push the
staple forward.
Figure 5
Stop moving the staple forward when the tips of its
legs are within 10-15 mm from the bone tunnel (5a).
Pinch the ligament using forceps to avoid damage to
it from the sharp point on the staple ends. Keeping the
ligament between the staple legs, adjust the Impactor
so that its axis is perpendicular to the surface of the
bone at the implantation site.
Figure 6
Pull on both the Impactor (6a) and free ligament end
(6b) to ensure tension on the section of the material
emerging from the bone tunnel (6c). During this step
the staple ends should not be pressed against the
bone until tension has been ensured.
Figure 7
While maintaining tension on the material (7a), hammer
the Fastlok into the bone (7b). Ensure that both staple
legs engage on the bone and that they do not skid
across the surface. This could cause the legs to splay
and possibly fracture.
Figure 8
Release the staple and close the jaws of the Impactor.
IMPORTANT: Rotate the Impactor through 90º and use
it to finish driving the staple (8a) into the bone while
maintaining tension on the ligament (8b).
Removing the Fastlok from Bone
Figure 9
Clamp the staple in the jaws of the Impactor (9a).
Figure 10
Screw the end of the Sliding Hammer into the end of
the Impactor.
Figure 11
Grip the handle (11a) on the Sliding Hammer and
hammer it against the end cap (11b) on the instrument.
Be careful not to trap fingers between the handle and
end cap.