BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, ELECTRIC DERMATOME

    MDR report key: 24941103 · Received April 21, 2026

    Report

    Report Number
    0001526350-2026-00477
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    April 10, 2026
    Report Date
    April 21, 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

    THIS INCIDENT IS BEING RECORDED UNDER (B)(4). G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. E1: (B)(6). D10: ZIMMER DERMATOME 1" WIDTH PLATE (ZI-00-8802-001-00) SN: UNK. ZIMMER DERMATOME 2" WIDTH PLATE (ZI-00-8802-002-00) SN: UNK. ZIMMER DERMATOME 3" WIDTH PLATE (ZI-00-8802-003-00) SN: UNK. ZIMMER DERMATOME 4" WIDTH PLATE (ZI-00-8802-004-00) SN: UNK. DERMATOME SCREWDRIVER (ZI-00-8803-000-00) SN: UNK. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, 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 · 0

    IT WAS REPORTED THAT DURING SURGERY THE UNIT WAS CUTTING OUT/LOSING POWER IN USE. IT IS UNKNOWN IF THERE WAS PATIENT IMPACT. DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997913 HANDPIECE, ELECTRIC DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11