inforMED
MalfunctionMDM

QUAD TENDON STRIPPER- CUTTER

Received Mar 5, 2026 · Event occurred Feb 11, 2026

Report 1220246-2026-01230 · MDR key 24518248

Device

Generic name

Manual Instr, General Surgical

Manufacturer

Arthrex, Inc.

Catalog number

AR-2384

Lot number

012530

Product problems

  • Use of Device Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ON 11-FEB-2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT A QTY. 2 OF AR-2384 QUAD TENDON STRIPPER-CUTTERS DID NOT WORK UPON THE SECOND USE OF THE DEVICE. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO PATIENT HARM.

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.