PARCUS MEDICAL GFS Naked Instrucciones De Uso página 3

I. This device has not been evaluated for safety and compatibility in the MR environment. This device
has not been tested for heating or migration in the MR environment. Use of MR technology in the
presence of devices of this nature may cause magnetically induced displacement forces and
torques, radio frequency heating and image artifacts. Standard MRI screening guidelines for post-
operative patients should be followed.
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 Parcus GFS Naked Product Family is comprised of Ti-6Al-4V ELI (ASTM F136).
7. Sterilization:
This Parcus GFS Naked Product Family is supplied sterile.
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 (Soft Tissue Graft)
A. A bone tunnel, appropriately sized to accommodate the graft and applicable GFS Naked, is
necessary for use of the GFS Naked device. Based on the implant chosen and size of graft used,
a stepped tunnel may be required. Please refer to product packaging for recommended diameter
for distal cortex.
B. Using an appropriately sized Drill Tip Guide Pin or Drill, create bone tunnel through to the outer
cortex of the bone. If tunnel is within the specified size of the implant per package labeling and
large enough to accommodate the graft, no further drilling or reaming is required. However, if
tunnel is not large enough, use of a cannulated drill or reamer is recommended. If utilizing a
stepped tunnel, use the Parcus GFS Depth Gauge to measure the tunnel in order to ensure that
the lateral cortex of the bone is not breached as that may compromise the strength of the fixation.
Note: If the lateral cortex of the bone is breached, use of a larger GFS Naked device may
be required.
C. Once the graft has been accurately measured using a Parcus Graft Sizer or Graft Sizing Block
and the tunnel has been prepared, the GFS Naked may be assembled to the graft.
D. Whipstitch the graft in the surgeon preferred manner, leaving suture tails long enough to be
placed through the two center holes of the GFS Naked fixation device. Aseptically open the
appropriately sized Parcus GFS Naked device and pass suture tails through center holes of
implant.
Note: The GFS Nano Naked can only accommodate suture up to #2 in size. However, all
larger sizes of GFS Naked can accommodate suture up to #5 in size.
E. Push the GFS Naked trough the tunnel using an appropriate instrument and then draw the graft
into position by pulling on the sutures lying along the length of the graft or pull the device through
the tunnel by adding accessory sutures, one each to either end of the device. Pass the sutures