MalfunctionHTN
KNOTLESS T-ROPE SYN-DESMOSIS REPR TI
Received Apr 17, 2026 · Event occurred Mar 12, 2026
Report 1220246-2026-02278 · MDR key 24911840
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
KNOTLESS T-ROPE SYN-DESMOSIS REPR TICatalog number
AR-8926T
Lot number
33696
Product problems
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
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
ON 30TH MAR 2026, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AR-8926T KNOTLESS T-ROPE SYN-DESMOSIS REPR TI BATCH 33696 SUTURE BROKE DURING PULLING. THIS WAS DETECTED DURING SYNDESMOSIS PROCEDURE ON (B)(6) 2026, AND NO PIECE(S) BREAK OFF INSIDE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE AND NO HARM CAUSED TO PATIENT.