PARCUS MEDICAL V-LoX Instrucciones De Uso página 3

5. Packaging and Labeling
A. Do not use this product if the packaging or labeling has been damaged, shows signs of exposure to moisture or extreme
temperature or has been altered in any way.
B. Please contact Parcus Medical Customer Service to report any package damage or alterations.
6. Material Specifications
The V-LoX Titanium Suture Anchor is supplied with or without needles attached to the high-strength, braided, polyethylene
polyblend sutures, The anchor material is Ti-6Al-4V ELI (ASTM F136).
7. Sterilization
The V-LoX Titanium Suture Anchor and driver are supplied in sterile packaging. The contents are sterilized by EO gas. These
products must never be re-sterilized.
8. Storage
Products must be stored in the original unopened package in a dry place and must not be used beyond the expiration date
indicated on the package.
9. Directions for Use
A. Identify bone of sufficient quantity and quality into which the anchor is to be placed.
Note: In cases where bone quality is suspect and the 4.5mm V-LoX Titanium Suture Anchor does not provide the
desired fixation, the larger diameter 5.5mm or 6.5mm V-LoX Titanium Suture Anchor may provide an alternative
solution.
B. Select the desired configuration (with or without needles) and aseptically open the package containing the V-LoX Titanium
Suture Anchor.
C. Taking care to create an entry to the desired placement site as close to perpendicular as possible, place the V-LoX Titanium
Suture Anchor and driver assembly through a suitable arthroscopic cannula, percutaneously, or in an open case, directly into
the wound. Using a suitable mallet, gently strike the driver handle until the threads of the anchor contact the bone.
D. Turn the driver handle clockwise until the circumferential laser etched line on the distal end of the driver shaft is flush with
the surrounding bone. If present the longitudinal lines on the driver shaft are used to indicate the orientation of the suture
passing around the post within the anchor. Placing the longitudinal lines in a plane perpendicular to the targeted tissue
offers the best orientation to allow the suture to slide through the anchor.
E. If the V-LoX Titanium Suture Anchor with Needles is selected, release the suture loops from the back of the handle and
disengage driver from anchor. The needles will now be loose and may be removed.
F. Two or three strands of polyethylene polyblend high strength suture either with or without needles are attached to the
anchor. Note that each strand is different color in order to aid in identification.
G. Pass the sutures through the targeted tissue in the user preferred arthroscopic manner. In open cases, use the needles to
pass the suture.
H. Complete the tissue repair by tying knots of the surgeon preferred configuration and cutting the suture tails above the knots.