KNOTLESS AC TIGHTROPE REPAIR SYSTEM
Received Sep 16, 2025 · Event occurred Aug 21, 2025
Report 1220246-2025-03892 · MDR key 23067174
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
KNOTLESS AC TIGHTROPE REPAIR SYSTEMCatalog number
AR-2371BL
Lot number
15330995
Product problems
- Break
- Break
Patient
NA · Unknown
- Failure of Implant
- Failure of Implant
Narrative
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Description of Event or Problem
IT WAS REPORTED THAT THE TIGHROPE BROKE POST OPERATIVELY. IT WAS FURTHER REPORTED THAT A REVISION SURGERY IS PLANNED. NO FURTHER INFORMATION RECEIVED. UPDATE 10-SEP-2025: ITS UNCLEAR WHEN THE INITIAL SURGERY WAS PERFORMED. HOWEVER, IT WAS FURTHER REPORTED THAT THE POST OPERATIVE COMPLIANCE WAS NOT FOLLOWED PROPERLY. THE REVISION SURGERY WAS ALREADY PERFORMED WITH A DEVICE FROM A COMPETITOR.