AREX LIGAMENTOTAXOR Notice D'utilisation page 6

PATIENT INFORMATION
Some degree of risk is inherent to all surgical procedures
and complications are sometimes unavoidable. It is the
surgeon's responsibility to explain fully the benefit-to-risk
ratio of the procedure under consideration. Potential com-
plications and caveats must be discussed with patients before
a decision is taken to proceed with surgery. The possibility
of discontinuing treatment at any point must also be made
clear to patients.
POSSIBLE COMPLICATIONS
AND WARNINGS
Complications which may arise as a result of all surgi-
cal procedures must be discussed with patients (infection,
haematoma, accumulation of fluids, loss of sensitivity, pain,
stiffness, finger deviation-deformity, Reflex Sympathetic
Dystrophy Syndrome, subluxation, possible allergic reaction
to medications used during surgery, nerve damage, patient
intolerance to a foreign body, imperfect healing).
SINGLE USE
Devices are designed for single use. Those removed after use
must not be used again since re-cleaning and re-sterilization
procedures may fail to eliminate with certainty biological
waste such as blood, tissues and other materials that could
contain resistant pathogenic germs.
PACKAGING
The devices are supplied sterile, processed by strictly vali-
dated and controlled sterilization cycles. Sterility is verified
to comply with current standards. Sterility of the device is
only guaranteed if packaging is inviolate and intact.
Removable labels to ensure traceability of the product are
supplied and attached to primary packaging.
DIRECTIONS FOR USE
Correct implementation of surgical procedures and tech-
niques are at the discretion of members of the medical
profession. Surgeons must individually evaluate the suit-
ability of the procedure on the basis of currently accepted
techniques, relying on their individual appreciation and
experience. The following is a description of placement of
the device as applicable to a PIP joint. Once the principle is
understood, its applicability can easily be extended to other
sites. An image intensifier must be made available.
The first KW is introduced transversally into the epiphyseal
axis of P1, ideally central to the rotational axis of the joint.
The second KW is introduced using the drill guide at P2
shaft level. Using the M 1.6TB, the distal KW is
ANOTTE
bent at a 90° angle on both sides of the finger. This KW is
then shortened as shown on the illustrated instructions for
use. Slide the two plastic rods over the proximal KW, one
on each side of the finger. Depending on the length of the
patient's fingers, use either the long green plastic rods or the
short blue ones. The long green rods are for long fingers.
Furthermore they will be helpful for lateral X-rays.
The spring is then 'screwed' onto the section of the distal
KW which is bent at 90° as shown on the photos. The
spring is then pushed halfway forward. (The joint's reac-
tion to ligamentotaxis can be tested by pulling the springs).
The plastic rod is then curved slightly as it is introduced
into the spring. The spring screwing procedure can then
be completed in order to achieve the required distraction.
N.B. Recommendation to facilitate the screwing in of the
spring: either pull on the spring while it is screwed in, or
alternatively, pull on one of the springs while the other
spring is screwed in, and continue likewise. The proximal
KW is bent at a 90° angle and cut on both sides of the
finger, leaving sufficient space for the rod to rotate without
rubbing against the skin. Finally, KW protective caps may
be placed at each end, but this is not mandatory since
the M 1.6TB pliers cut cleanly and precisely.
ANOTTE
To stabilise the springs, a frame is made using 1.5 mm KW.
The frame must be wide enough to allow each KW extrem-