K-LESS T-ROPE IMP ONLY, SYN REPR ,TI
Received Jul 7, 2026 · Event occurred Jun 10, 2026
Report 1220246-2026-03637 · MDR key 25734472
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
K-LESS T-ROPE IMP ONLY, SYN REPR ,TICatalog number
AR-8924T
Lot number
33405
Product problems
- Material Split, Cut or Torn
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
IT WAS REPORTED THAT DURING A STABILIZATION OF THE TIBIOFIBULAR SYNDESMOSIS THE SUTURE TORE AFTER THE BUTTON HAD BEEN SECURED TO THE TIBIA. THE IMPLANT WAS REMOVED. 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.