MalfunctionMDM
9MM TENDON STRIPPER BLA
Received Mar 26, 2026 · Event occurred Mar 6, 2026
Report 1220246-2026-01666 · MDR key 24698705
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
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A SURGERY IT WAS FOUND THAT THE BLADE IS DULL AND DOES NOT CUT INTO THE TENDON. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE A DIFFERENT PART NUMBER. 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.