InjuryHTN
KNOTLESS T-ROPE SYN-DESMOSIS REPR TI
Received Oct 3, 2025 · Event occurred Aug 13, 2025
Report 1220246-2025-04399 · MDR key 23211648
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
KNOTLESS T-ROPE SYN-DESMOSIS REPR TICatalog number
AR-8926T
Lot number
32780
Product problems
- Loosening of Implant Not Related to Bone-Ingrowth
- Loosening of Implant Not Related to Bone-Ingrowth
Patient
NA · Unknown
- Failure of Implant
- Failure of Implant
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AFTER A SURGERY ON (B)(6) 2025 THE DEVICE HAD LOOSENED AND HAD TO BE REVISED ON (B)(6) 2025. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.