K-LESS T-ROPE W/DRV, SYN REPR, SS
Received Mar 30, 2026 · Event occurred Mar 6, 2026
Report 1220246-2026-01701 · MDR key 24712932
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
15379715
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 09-MAR-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8925SS SYNDESMOSIS TIGHTROPE XP BROKE UPON INSERTION. THE SURGEON WAS PERFORMING FINAL TENSIONING WHEN ONE OF THE SUTURES SNAPPED WITHIN THE IMPLANT. THE CASE WAS COMPLETED BY LEAVING THE DAMAGED TIGHTROPE IN PLACE AND IMPLANTING AN ADDITIONAL TIGHTROPE ONE HOLE HIGHER. FLUOROSCOPIC IMAGING CONFIRMED NO FURTHER SYNDESMOTIC MOVEMENT. THIS ISSUE OCCURRED DURING A PROCEDURE ON (B)(6) 2026. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 11-MAR-2026: THIS OCCURRED DURING AN ISOLATED ANKLE SYNDESMOSIS REPAIR PROCEDURE. THE CASE WAS COMPLETED USING A REPLACEMENT AR-8925SS SYNDESMOSIS TIGHTROPE XP. THERE WAS NO CASE DELAY, NO ADDITIONAL ANESTHESIA TIME, AND THE BONE QUALITY WAS REPORTED AS NORMAL.