KNOTLESS T-ROPE SYN-DESMOSIS REPR KIT,SS
Received Jan 15, 2026 · Event occurred Dec 30, 2025
Report 1220246-2026-00217 · MDR key 24079065
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
KNOTLESS T-ROPE SYN-DESMOSIS REPR KIT,SSCatalog number
AR-8926SS
Lot number
32758
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 31-DEC-2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT (QTY. 2) OF AN AR-8926SS KNOTLESS T-ROPE EXPERIENCED A MALFUNCTION. WHEN THE DOCTOR PULLED THE SUTURES ONE BY ONE TO CLOSE THE SYNDESMOSIS, THE TIGHTROPE SUTURES BROKE; ANOTHER TIGHTROPE WAS PROVIDED TO PERFORM THE REPAIR, AND WHEN THE SUTURES WERE PULLED AGAIN, THEY BROKE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.