MalfunctionHTN
ARTHREX®
Received Nov 21, 2025 · Event occurred Oct 9, 2025
Report 23616758 · MDR key 23616758
Device
Generic name
Washer, Bolt Nut
Manufacturer
Arthrex, Inc.Model number
AR-8919DSCatalog number
AR-8919DS
Lot number
15475873
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ONE OF THE KWIRES LOOP BROKE DURING PROCEDURE. ARTHREX IMPLANT SYSTEM, CMC MINI TIGHTROPE, 1.1MM REF AR-8919DS; LOT 15475873, EXP 06/30/2030. BROKEN LOOP PIECE RECOVERED.