K-LESS T-ROPE W/DRV, SYN REPR, TI
Received Jun 5, 2026 · Event occurred May 15, 2026
Report 1220246-2026-03250 · MDR key 25411321
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
15566528
Product problems
- Physical Resistance/Sticking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON 20TH MAY 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-8925T, SYNDESMOSIS TIGHTROPE® XP, TITANIUM, AFTER THE ANCHOR WAS PLACED IN THE BONE HOLE, TENSION WAS APPLIED, BUT ONE END OF THE SUTURE GOT STUCK AND IT DID NOT TIGHTEN COMPLETELY. THIS WAS DETECTED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A PRODUCT WITH THE SAME PART NUMBER.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.