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Parcus Graft Fixation System Product Family (GFS, GFS II and GFS Mini) (English)
1. Indications: The Parcus GFS devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. 2. Contraindications: A. Any active infection. B. Blood supply limitations or other systemic conditions that may retard healing. C. Foreign body sensitivity, if suspected, should be identified and precautions observed. D. Insufficient quality or quantity of bone. E. Patient’s inability or unwillingness to follow surgeon’s prescribed post-operative regimen. F. Any situation that would compromise the ability of the user to follow the instructions for use or using the device for an indication other than those listed. 3. Adverse Effects: A. Infection, both deep and superficial. B. Allergies and other reactions to device materials. C. Risks due to anesthesia. 4. Warnings: A. Caution: Federal Law restricts this device to sale by or on the order of a physician. B. The fixation provided by this device should be protected until healing is complete. Failure to follow the postoperative regimen prescribed by the surgeon could result in the failure of the device and compromised results. C. Size selection of the implant should be made with care taking into consideration the quality of the bone on which the implant will rest and the desired length of graft that will reside in the tunnel. D. Any decision to remove the device should take into consideration the potential risk of a second surgical procedure. An adequate postoperative management plan should be implemented after implant removal. E. Pre-operative planning and evaluation, surgical approaches and technique, and familiarity of the implant, including its instrumentation and limitations are necessary components in achieving a good surgical result. F. This device must never be reused. Reuse or re-sterilization may lead to changes in material characteristics such as deformation and material degradation which may compromise device performance. Reprocessing of single use devices can also cause cross-contamination leading to patient infection. G. This device must never be re-sterilized. H. Appropriate instrumentation should be used to implant this device. I. The GFS Mini is intended to be used with a stepped tunnel technique. Failure to follow this technique may result in premature failure of fixation. J. 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 postoperative 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 Product Family is supplied with high-strength, braided, polyethylene polyblend sutures. The anchor material is Ti-6Al-4V ELI (ASTM F136). 7. Sterilization: This Parcus GFS 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. Instructions for Use (Soft Tissue Graft) A. A bone tunnel, appropriately sized to accommodate the graft, is created from the medial aspect of the lateral femoral condyle through to the lateral femoral cortex.
Note: To use the GFS Mini device, a stepped tunnel is required to achieve adequate fixation for the smaller device. The stepped tunnel may be no larger than 5mm at its exit point on the lateral femoral cortex. Create the stepped tunnel by 1) drilling a 5mm drill, or cannulated reamer over a guide wire, from the medial aspect of the lateral femoral condyle, so that it passes through the femur and exits the lateral femoral cortex 2) create a socket of the desired depth and diameter to accommodate the graft, taking care to avoid breeching the lateral femoral cortex. Add 8mm to the depth of the graft socket to allow proper positioning of the GFS Mini implant (see example in step D below).
Note: The Parcus GFS Product Family is supplied in sizes to be used with specific tunnel diameters. See package label for details.
B. Measure the overall length of the tunnel with the Parcus GFS Depth Gauge. C. Subtract the amount of graft to be placed into the tunnel from the overall tunnel length. D. The remainder will be the length of the loop required to position the desired amount of graft in the tunnel. If “T” equals the tunnel length and “G” equals the desired length of graft to be inserted into the tunnel and “L” equals the length of Loop required to leave the desired graft in the tunnel then TG=L For example:
Tunnel length
= 45mm
Graft in Tunnel
= 25mm
Loop length
= 20mm
Note: When using the GFS Mini, add 8mm to the “Graft in Tunnel” drill depth to allow the GFS Mini implant to be properly positioned on the lateral femoral cortex.
E. Aseptically open the appropriately sized Parcus GFS device. Remove the foil wrapper from the suture loops and draw one end of the prepared soft tissue graft, through the space between the titanium implant and the end of the loop. Parcus recommends whip-stitching the free ends of the graft to aid in tensioning the graft and to improve graft fixation. F. Position the loops of suture at the midpoint of the length of the graft. G. Orient the GFS/Graft construct in such a way that the axis of the titanium implant is parallel to the graft. Place the end of the titanium component at the zero point on the GFS Depth Gauge and make a mark on the graft with a surgical marker that corresponds to the length of the femoral tunnel described as dimension “T” above. This will indicate the point at which the tip of the GFS component has passed the lateral femoral cortex. See Drawing “A” below.
drawing A H. When using the Parcus GFS device for ACL or PCL reconstruction, select a suture passing device (e.g. Parcus Drill Tip Guide Pins with Eyelet) that will allow the user to pass the leading suture and colored toggle suture (the colored toggle suture will only be present in GFS II and GFS Mini configurations) of the GFS device through the tibial tunnel and exit out the femoral tunnel. I. Once the leading and toggle sutures can be retrieved, grasp them with a hemostat or similar instrument. Pull the graft into the femoral tunnel using the white leading suture until the mark, described in “G” passes into the tunnel opening. Note: If using the GFS II or GFS Mini, ensure that the colored suture is slightly tensioned, but the main pulling force is applied to the white leading suture. Once the mark, described in “G” passes into the tunnel opening, relax the tension on the white leading suture and apply force to the colored toggle suture in order to flip the titanium component into position. J. Using the sutures attached to the free ends of the graft, pull the graft in a caudad direction. This movement will secure the titanium component of the device to the femoral cortex and orient the GFS device over the tunnel opening. Pull vigorously on the ends of the graft to determine if the implant is properly deployed. If fixation is not achieved remove the graft and repeat step “I”. K. Tension the graft by pulling the sutures exiting the tibial tunnel. L. Fix the distal end of the graft in the tibial tunnel according to user preference. M. Once secure fixation has been verified, remove the leading and toggle sutures.