KNOTLESS T-ROPE SYN-DESMOSIS REPR TI
Received Dec 9, 2025 · Event occurred Nov 21, 2025
Report 1220246-2025-05520 · MDR key 23758104
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
KNOTLESS T-ROPE SYN-DESMOSIS REPR TICatalog number
AR-8926T
Lot number
33256
Product problems
- Material Split, Cut or Torn
- Material Split, Cut or Torn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- 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
IT WAS REPORTED THAT DURING THE SURGERY TO TREAT CHRONIC SYNDESMOTIC INSTABILITY THE SUTURE OF THE TIGHTROPE TORE WHEN TIGHTENED. THE TORN PIECES WERE REMOVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.