MalfunctionHTN
K-LESS T-ROPE W/DRV, SYN REPR, SS
Received Feb 24, 2026 · Event occurred Feb 3, 2026
Report 1220246-2026-00875 · MDR key 24427779
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
15382725
Product problems
- Material Split, Cut or Torn
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 06-FEB-2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT WHEN ADJUSTING AN AR-8925SS SYNDESMOSIS TIGHTROPE, PULLING ON THE SUTURES CUTS THEM. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM REPORTED.