K-LESS T-ROPE W/DRV, SYN REPR, TI
Received Mar 24, 2026 · Event occurred Feb 26, 2026
Report 1220246-2026-01622 · MDR key 24680641
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
15481872
Product problems
- Material Frayed
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 26-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-8925T SYNDESMOSIS TIGHTROPE FAILED DURING A PROCEDURE. THIS OCCURRED DURING AN ANKLE FRACTURE ON (B)(6) 2026; THE MEDIAL BUTTON SUTURES APPEAR TO BE FRAYED. THIS WAS DISCOVERED UPON CLOSING THE PATIENT. THE SURGEON DECIDED TO REMOVE THE DEVICE. THIS DELAYED THE CASE APPROXIMATELY 10 MINUTES, AND IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE CASE WAS COMPLETED USING ANOTHER AR-8925T SYNDESMOSIS TIGHTROPE. THERE WAS NO HARM TO THE PATIENT.