K-LESS T-ROPE W/DRV, SYN REPR, SS
Received Mar 18, 2026 · Event occurred Feb 24, 2026
Report 1220246-2026-01479 · MDR key 24634535
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
K-LESS T-ROPE W/DRV, SYN REPR, SSCatalog number
AR-8925SS
Lot number
15306397
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 25-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8925SS SYNDESMOSIS TIGHTROPE XP EXPERIENCED AN ISSUE DURING AN ANKLE FRACTURE REPAIR PROCEDURE PERFORMED ON (B)(6) 2026. WHILE TENSIONING THE TIGHTROPE XP, THE SUTURES BROKE BEFORE FINAL FIXATION COULD BE ACHIEVED, AND THE SUTURES APPEARED TO HAVE BROKEN AT THE LATERAL BUTTON. THE MEDIAL INCISION HAD ALREADY BEEN MADE FOR THE ASSOCIATED MEDIAL FRACTURE, WHICH ALLOWED THE SURGEON TO REMOVE BOTH THE MEDIAL AND LATERAL BUTTONS. A NEW TIGHTROPE IMPLANT WAS THEN OPENED AND USED TO COMPLETE THE FIXATION. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 02-MAR-2026: THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.