Neoligaments Infinity-Lock Button System Anwendung Seite 6

Surgical Technique
1. With the patient in the beach chair position use
a vertical 5 cm skin incision starting at the level
of the clavicle and slightly medial to the tip of
the coracoid. Incise the fascia and the deltoid
vertically and then divide the periosteum over the
posterior clavicle laterally as far as the AC joint.
2. Carry out a sub-periosteal dissection creating an
"L " shaped flap then insert a stay suture into the
apex of the flap to aid retraction.
3. Gently apply a self-retaining retractor to aid
access to the coracoid process. Take care to clear
soft tissues from around the coracoid to enable
the Tube-Tape to sit securely.
4. Insert a cholecystectomy-type forceps under
the coracoid and follow this with the coracoid
passer, passed under the neck of the coracoid
from medial to lateral. See the coracoid passer
instructions for use for further details.
5. Capture the green lead suture of the Tube-Tape
with the coracoid passer (Figure 1) and pull it
medially under the coracoid so that the loop of
the Tube-Tape is accessible (Figure 2). Remove
the lead suture when satisfied.
6. Pass both limbs of the Tube-Tape through
the loop, lassoing the coracoid. Move the
Tube-Tape from side-to-side to tighten it down
onto the coracoid.
7. Identify the tuberosity on the inferior surface of
the clavicle to which the conoid ligament was
attached before being avulsed. Alternatively
identify a point 3 to 3.5 cm from the un-excised
lateral end of the clavicle.
8. Reduce the end of the clavicle to the normal
anatomical position by pushing downward on
it while the elbow is simultaneously pushed
upward. Ensure this position is maintained in the
subsequent steps of the procedure.
9. Drill the 2 mm guidewire perpendicularly through
the middle of the clavicle at the point identified.
10. Over-drill with the 4 mm cannulated drill bit
to create the final bone tunnel in the clavicle.
Chamfer the upper edges of the tunnel to
prevent abrasion of the Tube-Tape. Take care to
leave sufficient bone around the tunnel to resist
expected forces.
11. Adjust the angle of the loop around the coracoid
to minimise the distance from the exit of the bone
tunnel to the point at which the limbs of the Tube-
Tape exit the loop. Take care to ensure the loop
remains fully tightened.
12. Use a suture and needle to pass the limbs of the
Tube-Tape through the bone tunnel, one at a time.
Alternatively this may be performed with the nitinol
wire from the CC-Hook, if being used (Figure 3).
13. Pass the limbs of the Tube-Tape through the
central holes of the Infinity-Lock Button, using
the suture and needle if necessary (Figure 4).
While maintaining the previous reduction, apply
appropriate tension to the Tube-Tape (Figure 4).
Take care to avoid damaging the Tube-Tape. If
desired an optional half-knot may be tied over the
top of the Button (Figure 5) but avoid creating a
knot stack (Figure 6).
14. Check the repair is physiological and does not
affect range of motion. When satisfied pass the
ends of the Tube-Tape either side of the clavicle
and secure inferiorly with a surgeons knot (Figures
5 & 7). If there is insufficient space below the
clavicle the knot may be tied anteriorly. Ensure the
knot is securely locked.
15. Cut any excess Tube-Tape with scissors at right
angles to its length to minimize the generation of
loose fibres (Figure 8). Take care to remove any
loose fibres that are created. Stitch the cut ends of
Tube-Tape back on itself (Figures 5 & 7).
16. Repair the soft tissues by re-attaching the
"L " shaped flap while tensioning the superior
acromioclavicular ligament during the repair.
Ensure the cut ends of the Tube-Tape are well
buried in tissue.
Disposal
No specific disposal requirements other than handling
contaminated items as clinical waste.
Device Retrieval Methods
Should it be necessary to remove an Infinity-Lock
Button System device, contact Xiros prior to the
scheduled surgery for product/tissue retrieval
information.
Complaints
Any health care professional who has any complaints
or experienced any dissatisfaction in the product
quality, identity, durability, reliability, safety, usability,
effectiveness, and/or performance, should notify
the manufacturer and distributor immediately.
If the product ever malfunctions and may have caused
or contributed to the death or serious injury of a
patient, the manufacturer and relevant local regulatory
authority should be notified immediately by
telephone, email or written correspondence.
When filing a complaint, provide the component(s)
name and number, lot number(s), your name and
contact details and the nature of the complaint.