MalfunctionMDM
9MM TENDON STRIPPER BLA
Received Apr 27, 2026 · Event occurred Apr 3, 2026
Report 1220246-2026-02483 · MDR key 25001308
Device
Generic name
Manual Instr, General Surgical
Manufacturer
Arthrex, Inc.Model number
9MM TENDON STRIPPER BLACatalog number
AR-2385-09
Lot number
15563772
Product problems
- Dull, Blunt
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON 03-APR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-2385-09 9MM TENDON STRIPPER AND AN AR-2385-10 TENDON STRIPPER BLADE WERE DULL. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THE FACILITY WOULD LIKE TO RETURN THE REST OF THE LOT.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.