MalfunctionHTN
IMPL SYS,CMC MINI T-ROPE,1.1 MM
Received Apr 27, 2026 · Event occurred Apr 3, 2026
Report 1220246-2026-02484 · MDR key 25001432
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
15499596
Product problems
- Break
Patient
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 03-APR-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-8919DS CMC MINI T-ROPE KIT HAD BOTH NITINOL LOOPS BREAK OFF DURING A CASE. THIS ISSUE WAS ALLEVIATED BY OPENING A SECOND KIT, AND THE CASE WAS ABLE TO BE COMPLETED WITH NO ADVERSE EFFECT TO THE PATIENT.