Directions For Use Passing Suture Through Shoulder Labrum Tissue - Ceterix NovoStitch Instructions For Use Manual

thick to reliably deliver the suture. If the jaw does not compress and if there is an appropriate target
more centrally, reposition the device in thinner tissue so that the upper jaw does show compression
when squeezing Lever A.
5. When in position, exert additional forward force in line with the shaft prior to and during needle
deployment. Slowly deploy the needle by simultaneously squeezing Levers A and B (see Figure 1
above) until Lever B is fully advanced. Forward pressure on the device prior to and during
deployment will prevent the tissue from migrating distally. Distal tissue migration during
deployment may lead to suture misfire.
6. During deployment, the suture outside of the access port should be observed advancing in tandem
with the needle-trigger advancement. If the suture does not advance, or if the suture breaks, the
suture may be pinched between the device and the surrounding structures. If this occurs, consider
adjusting the patient position before redeploying the needle. Positioning the lower jaw beyond the
meniscus may lead to suture misfire.
7. Release both Levers A and B and then retract the lower jaw by pushing down Lever C.
Simultaneously pull the device proximally and engage Lever A to remove the upper jaw from
between the superior surface of the meniscus and femoral condyle. Keep Lever A engaged when
withdrawing the device from the joint in order to keep the upper jaw parallel with the shaft.
Remove the suture end from the upper jaw by pulling in the proximal direction, parallel to the upper
jaw.
8. If needed, repeat steps 2 through 8 using the opposing suture end. This will create a circumferential
stitch.
9. Using standard surgical techniques and the Ceterix Knot Pusher Suture Cutter or commercially-
available equivalent(s), advance a knot to the surface of the tissue until tissue approximation at the
tear is observed. Place the appropriate number of additional throws to ensure that the knot is
secure. Trim the suture limbs from the knot.
C. DIRECTIONS FOR USE PASSING SUTURE THROUGH SHOULDER LABRUM TISSUE
1. Advance the device with the upper jaw following the radius of the humeral head. Release Lever A as
the upper jaw is positioned above the labral tear.
2. When the upper jaw is in position, with all fingers on the white handle (not on Lever A) fully advance
the lower jaw by squeezing Lever B (see Figure 1 above). Ensure that the lower jaw slides into the
tear, then release Lever B.
3. When both upper and lower jaws are in position, simultaneously squeeze Lever A and apply slight
forward pressure to prevent the tissue from migrating distally. Arthroscopically observe upper jaw
movement. Lack of upper jaw compression during upper jaw clamping is a sign that the tissue is too
thick to reliably deliver the suture. If the jaw does not compress and if there is an appropriate target
more proximally, reposition the device so that the upper jaw does show compression when
squeezing Lever A.
P/N: LBL-0012 Rev: E Page 5