K-LESS T-ROPE W/DRV, SYN REPR, SS
Received Mar 16, 2026 · Event occurred Feb 19, 2026
Report 1220246-2026-01426 · MDR key 24607433
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
UNK
Product problems
- Break
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
ON (B)(6), IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8925SS SYNDESMOSIS TIGHTROPE XP SUTURE BROKE PREMATURELY DURING TENSIONING. THE IMPLANT WAS REMOVED FROM THE PATIENT. THIS ISSUE WAS DISCOVERED DURING A SYNDESMOSIS REPAIR PROCEDURE ON (B)(6). ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6): TWO AR-8925SS SYNDESMOSIS TIGHTROPE XP DEVICES EXPERIENCED PREMATURE SUTURE BREAKAGE DURING TENSIONING. TWO ADDITIONAL AR-8925SS DEVICES WERE OPENED TO COMPLETE THE PROCEDURE, AND THE PROCEDURE CONTINUED WITHOUT FURTHER ISSUE. THE CASE WAS DELAYED BY APPROXIMATELY FIVE MINUTES TO REMOVE THE BROKEN TIGHTROPE AND PLACE A NEW ONE. NO ADDITIONAL ANESTHESIA WAS REQUIRED.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION