BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, ELECTRIC DERMATOME

    MDR report key: 24758084 · Received April 1, 2026

    Report

    Report Number
    0001526350-2026-00380
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 30, 2026
    Report Date
    April 1, 2026
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) D10: MEDICAL PRODUCTS: 1 INCH WIDTH PLATE 00-8802-001-00, LOT#: UNK, SERIAL#: UNK 2 INCH WIDTH PLATE 00-8802-002-00, LOT#: UNK, SERIAL#: UNK 3 INCH WIDTH PLATE 00-8802-003-00, LOT#: UNK, SERIAL#: UNK 4 INCH WIDTH PLATE 00-8802-004-00, LOT#: UNK, SERIAL#: UNK SCREW DRIVER 00-8803-000-00, LOT#: UNK, SERIAL#: UNK G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET. ONCE THE PRODUCT IS RETURNED AND THE INVESTIGATION IS COMPLETE, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY THE DERMATOME STOPPED WORKING MIDWAY WHEN SURGEON WAS USING IT. LATER, THE LEVER WAS PRESSED TO RUN THE UNIT, AND IT WAS WORKING/ RUNNING BUT SOUNDS AS THOUGH IT HAS DECREASED CAPACITY. PATIENT IMPACT IS UNKNOWN. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814881 HANDPIECE, ELECTRIC DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown