MalfunctionMDM
9MM TENDON STRIPPER BLA
Received Jun 9, 2026 · Event occurred May 22, 2026
Report 1220246-2026-03304 · MDR key 25445600
Device
Generic name
Manual Instr, General Surgical
Manufacturer
Arthrex, Inc.Model number
9MM TENDON STRIPPER BLACatalog number
AR-2385-09
Lot number
15533289
Product problems
- Dull, Blunt
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING THE CRUCIATE LIGAMENT SURGERY, IT WAS FOUND THAT THE BLADE IS DULL. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.