MalfunctionHTN
MINI TIGHTROPE REPAIR
Received May 8, 2026 · Event occurred Apr 22, 2026
Report 1220246-2026-02738 · MDR key 25123847
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
MINI TIGHTROPE REPAIRCatalog number
AR-8911DS
Lot number
34065
Product problems
- Break
Patient
NA · 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 22ND APRIL 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-8911DS, MINI TIGHTROPE® REPAIR KIT, CANNULATED, STAINLESS STEEL, THE PASSING PIN OF THE IMPLANT WAS BROKEN. THIS WAS DETECTED DURING A LISFRANC PROCEDURE ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A NEW IMPLANT. THERE WAS NO PATIENT HARM.