Local restrictions and curfews in certain areas across the U. For the latest information, please check the FedEx website. We currently do not have this item in stock, but we can email you as soon as it is available. The ACL TightRope RT allows surgeons to advance the graft by pulling the tensioning strands in the same direction of graft advancement. This innovation eliminates the need to retrieve shortening strands from the joint and allows the surgeon to pull in-line with graft advancement.
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It was reported that during an all inside acl reconstruction, the tightrope snapped on the tibial side as the surgeon was running the knee through range of motion testing. The end of the graft could be seen, therefore, the surgeon knew the graft had migrated.
The surgeon enlarged the incision on the tibial side to locate the button. The button remained attached to the suture and the surgeon was able to remove it. The graft and the button on the femoral side were also removed through the already made incision. Another graft was prepared; the surgeon changed techniques and implanted a competitor's screw on the tibia.
The case was completed successfully. Bone preparation was done using a flip cutter on the tibia and a 9 mm low profile reamer was used on the femoral side. The graft size was 9 mm. The patient had good bone quality. No further patient information was provided at the time of this report or made available in response to follow-up communication.
No additional adverse consequences have been reported from this event. This device is used for treatment. The device was received and an evaluation was conducted.
Device history record revealed nothing relevant to this event. Returned device include a button assembled with part of the suture loop construct. The suture appears to be cut between where the loop is created and the tightening suture strand above the button. The graft construct is the longest when the knee is in extension. If the loop constructs are tightened to its maximum with the knee in flexion, the graft construct may fail during extension. There are no sharp edges or burrs found on the button.
The potential cause s of this event will be communicated to the event reporter. If additional relevant information is received, a follow-up report will be submitted. Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Search FDA. Food and Drug Administration. For Government For Press. Adverse Events. CFR Title Radiation-Emitting Products. X-Ray Assembler. Medsun Reports. Manufacturer Narrative.
The TightRope CCL technique was developed to provide a minimally invasive method for extracapsular stabilization of the cranial cruciate ligament—deficient canine stifle. The TightRope CCL technique seeks to optimize the lateral suture stabilization technique by employing bone-to-bone fixation that provides implant strength and stiffness. It is designed specifically for ligament repair and provides a method for consistent isometric implant placement. TightRope CCL fixation can help counteract cranial tibial thrust, drawer, and internal rotation while providing optimal joint range of motion. This website uses its own cookies and cookies from analytical services to provide its services, personalize advertisements, and analyze traffic. Data on your use of this website will be passed on to the providers of the analytical services. By agreeing to the use of these cookies, you also consent to processing by the cookies.
MAUDE Adverse Event Report: ARTHREX, INC. ACL TIGHTROPE RT PIN, FIXATION, SMOOTH
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ACL TightRope, sterile, SU - AR-1588T
It was reported that during an all inside acl reconstruction, the tightrope snapped on the tibial side as the surgeon was running the knee through range of motion testing. The end of the graft could be seen, therefore, the surgeon knew the graft had migrated. The surgeon enlarged the incision on the tibial side to locate the button. The button remained attached to the suture and the surgeon was able to remove it. The graft and the button on the femoral side were also removed through the already made incision. Another graft was prepared; the surgeon changed techniques and implanted a competitor's screw on the tibia.