MalfunctionMDM
TIGHTROPE SUTURE TENSIONER
Received Jul 7, 2026 · Event occurred Jun 8, 2026
Report 1220246-2026-03641 · MDR key 25735540
Device
Generic name
Orthopedic Manual Surg Instr
Manufacturer
Arthrex, Inc.Model number
TIGHTROPE SUTURE TENSIONERCatalog number
AR-1588H
Lot number
37621939
Product problems
- Break
- Naturally Worn
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
IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE BROKE WHEN TENSION WAS APPLIED. THE DEVICE WAS ALREADY WORN. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.