MalfunctionHTN
K-LESS T-ROPE W/DRV, SYN REPR, TI
Received Jan 12, 2026 · Event occurred Dec 26, 2025
Report 1220246-2026-00164 · MDR key 24039506
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
K-LESS T-ROPE W/DRV, SYN REPR, TICatalog number
AR-8925T
Lot number
15502038
Product problems
- Break
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
ON 26TH DECEMBER 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-8925T, SYNDESMOSIS TIGHTROPE® XP, TITANIUM, THE NURSE STATED THAT THE IMPLANT WAS FAULTY AND THE TIGHTROPE SUTURE BROKE WHEN IT WAS BEING USED. THIS WAS DETECTED DURING AN ANKLE ORIF PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A NEW IMPLANT WAS OPENED.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.