inforMED
MalfunctionHTN

MINI TIGHTROPE REPAIR

Received Mar 25, 2026 · Event occurred Mar 5, 2026

Report 1220246-2026-01628 · MDR key 24686660

Device

Generic name

Washer, Bolt, Nut

Manufacturer

Arthrex, Inc.

Catalog number

AR-8911DS

Lot number

34065

Product problems

  • Break

Patient

NA · Unknown

  • Insufficient Information

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 05TH MAR 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AR-8911DS MINI TIGHTROPE REPAIR BATCH 34065 SNAPPED WHEN DEPLOYING. THIS WAS DETECTED ON THE SAME DAY DURING PROCEDURE.