inforMED
MalfunctionGFD

HANDPIECE, ELECTRIC DERMATOME

Received May 19, 2026

Report 0001526350-2026-00585 · MDR key 25214969

Device

Generic name

Dermatome

Catalog number

00882100100

Lot number

UNK

Product problems

  • Corroded
  • Material Deformation
  • Naturally Worn

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). G2: FOREIGN - EVENT OCCURRED IN BELGIUM. THE DEVICE WILL BE RETURNED FOR ANALYSIS, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE WAS RETURNED FOR PREVENTATIVE MAINTENANCE. DURING ROUTINE MAINTENANCE, IT WAS DISCOVERED THAT THE DEVICE NEEDED REPAIR. UPON RECEIPT OF THE DEVICE, REPAIR WAS NEEDED FOR DAMAGED WIDTH PLATE, WORN RECIPROCATION ARM AND CORRODED MOTOR. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. AS NO ADDITIONAL INFORMATION IS AVAILABLE, WE ARE UNABLE TO PROVIDE FURTHER INFORMATION.