KNOTLESS T-ROPE SYN-DESMOSIS REPR TI
Received Jun 3, 2026 · Event occurred May 18, 2026
Report 1220246-2026-03190 · MDR key 25375471
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
KNOTLESS T-ROPE SYN-DESMOSIS REPR TICatalog number
AR-8926T
Lot number
34560
Product problems
- Patient Device Interaction Problem
Patient
NA · Unknown
- Bone Notching
Narrative
Description of Event or Problem
ON 18TH MAY 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-8926T, KNOTLESS TIGHTROPE® SYNDESMOSIS REPAIR IMPLANT, TITANIUM, THE IMPLANT BUTTON CUT THROUGH THE BONE (FIBULA) DURING TENSIONING. THIS WAS DETECTED DURING A SYNDESMOSIS FIXATION ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A NEW IMPLANT. A NEW IMPLANT WAS USED ON A NEW SITE. ADDITIONAL INFORMATION RECEIVED ON 20TH MAY 2026: NOTHING BROKE OFF IN THE PATIENT, BUT THE SURGEON REMOVED THE FAULTY IMPLANT BEFORE REINSERTING ANOTHER ONE.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.