IMPL SYS,CMC MINI T-ROPE,1.1 MM
Received Dec 9, 2025 · Event occurred Oct 9, 2025
Report 1220246-2025-05522 · MDR key 23759099
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
IMPL SYS,CMC MINI T-ROPE,1.1 MMCatalog number
AR-8919DS
Lot number
15475873
Product problems
- Break
- Break
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
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 11/21/2025, AN FDA MEDSUN NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT ONE OF THE K-WIRE LOOPS FROM AN AR-8919DS CMC MINI TIGHTROPE IMPLANT SYSTEM BROKE. THE BROKEN LOOP PIECE WAS RETRIEVED. THIS INCIDENT WAS DISCOVERED IN A PROCEDURE IN (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 12/02/2025: THIS OCCURRED ON (B)(6) 2025.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: G3, H3, H6 BASED ON THE INFORMATION PROVIDED ¿ WHICH MAY INCLUDE THE RETURNED DEVICE (IF AVAILABLE), PHOTOGRAPHS, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL FIELD INPUT ¿ ARTHREX HAS DETERMINED THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE IS ATTRIBUTED TO USER-RELATED FACTORS SUCH AS OVER-TENSIONING AND EXCESSIVE FORCE APPLIED WHEN PULLING THE SUTURE THROUGH THE K-WIRE LOOP.