K-LESS T-ROPE W/DRV, SYN REPR, TI
Received Mar 26, 2026 · Event occurred Mar 8, 2026
Report 1220246-2026-01688 · MDR key 24705689
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
15502038
Product problems
- Device Dislodged or Dislocated
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
ON 09 MAR 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AR-8925T K-LESS T-ROPE W/DRV, SYN REPR, TI BATCH 15502038 WAS PULLED OUT IN ITS WHOLE CONSTRUCT WHEN TUGGING IN THE LATERAL DIRECTION TO FLUSH THE OBLONG MEDIAL BUTTON TO BONE. POSSIBLY DUE TO CATCHING SOFT TISSUES ON THE MEDIAL SIDE BY THE OBLONG BUTTON, CAUSING IMPROPER SITTING OF OBLONG BUTTON. THIS WAS DETECTED DURING ANKLE FRACTURE & SYNDESMOSIS TIGHTROPE PROCEDURE ON (B)(6) 2026. NO FRAGMENTS RETAINED IN THE PATIENT¿S BODY AND PROCEDURE WAS COMPLETED SUCCESSFULLY.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.