MalfunctionMDM
10MM TENDON STRIPPER BLADE
Received Apr 20, 2026 · Event occurred Mar 23, 2026
Report 1220246-2026-02283 · MDR key 24924051
Device
Generic name
Manual Instr, General Surgical
Manufacturer
Arthrex, Inc.Model number
10MM TENDON STRIPPER BLADECatalog number
AR-2385-10
Lot number
24P09
Product problems
- Contamination
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON 30-MAR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-2385-10 10MM QUAD TENDON GRAFT CUTTING BLADE HAD RUST OR SOME DARK ORANGE RESIDUE ON THE BLADE. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED WITH ANOTHER DEVICE.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.