MINI TIGHTROPE IMPLANT WITH INSERTER
Received Apr 30, 2026 · Event occurred Apr 14, 2026
Report 1220246-2026-02572 · MDR key 25044358
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
MINI TIGHTROPE IMPLANT WITH INSERTERCatalog number
AR-8913DS
Lot number
15485689
Product problems
- Break
Patient
Not reported
- 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 (B)(6) 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-8913DS, MINI TIGHTROPE® WITH INSERTER, AFTER THE BUTTONS WERE PLACED, THE FW SLID AS IT WAS BEING TIGHTENED ONE BY ONE, EVENTUALLY BREAKING. THE DOCTOR SAID THAT THE FW FELT DIFFERENT WHEN IT WAS BEING TIGHTENED THE FIRST TIME AS WELL. THIS WAS DETECTED DURING USE IN AN UNSPECIFIED PROCEDURE ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE BUTTONS INSIDE THE BODY WERE RETRIEVED AND NEW ONES WERE INSERTED. NO SIGNIFICANT SURGERY DELAY REPORTED. NO ADDITIONAL ANESTHESIA ADMINISTERED TO THE PATIENT.