MINI TIGHTROPE FT
Received Dec 26, 2025 · Event occurred Dec 2, 2025
Report 1220246-2025-05824 · MDR key 23896121
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
MINI TIGHTROPE FTCatalog number
AR-8917DS
Lot number
15464998
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D9, G3, H3, H6. ONE UNPACKAGED AR-8917DS BATCH 15464998 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED THAT THE ANCHOR WAS FRACTURED. THE DEVICE WAS RETURNED WITHOUT THE SUTURES. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO OFF-AXIS INSERTION, PRYING, AND LEVERAGING THE DEVICE WITH EXCESSIVE FORCE.
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 04-DEC-2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT THE TIP OF THE DRIVER BROKE WHILE INSERTING THE SCREW OF AN AR-8917DS MINI TIGHTROPE FT INTO AN INTERMEDIATE WEDGE-SHAPED BONE HOLE. THE SCREW WAS SUCCESSFULLY PLACED, AND ALL BROKEN FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT AR-8917DS MINI TIGHTROPE FT. THE EVENT OCCURRED DURING A PROCEDURE ON (B)(6) 2025. NO DETAILED INFORMATION WAS PROVIDED REGARDING THE TYPE OF SURGERY. THERE WAS NO SIGNIFICANT DELAY, NO ADDITIONAL ANESTHESIA ADMINISTERED, AND NO ADVERSE EFFECTS REPORTED. NO PHOTOS WERE TAKEN.