BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 23456956 · Received November 3, 2025

    Report

    Report Number
    0001526350-2025-01387
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    October 29, 2025
    Report Date
    June 5, 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). G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. E1: TELEPHONE: (B)(6). D101: 1 INCH WIDTH PLATE (00-8802-001-00) SN: UNK. 2 INCH WIDTH PLATE (00-8802-002-00) SN: UNK. 3 INCH WIDTH PLATE (00-8802-003-00) SN: UNK. 4 INCH WIDTH PLATE (00-8802-004-00) SN: UNK. AIR HOSE (00-8801-002-00) SN: UNK. SCREWDRIVER (00-8803-000-00). WIDTH PLATE SCREWS - TWO (00-8803-001-10). THERAPY DATE: ON (B)(6) 2025. 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 THE DEVICE WAS NOT ABLE TO GRAFT SKIN WHEN TURNED ON DURING SURGERY. IT IS UNKNOWN IF THERE WAS ANY HARM OR SURGICAL DELAY. NO ADDITIONAL INFORMATION WAS NOTED AS RESULT DILIGENCE IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052967 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown REFER TO H11.