BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMATOME AN HANDPIECE

    MDR report key: 24377846 · Received February 18, 2026

    Report

    Report Number
    0001526350-2026-00169
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    February 13, 2026
    Report Date
    February 18, 2026
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). G2: FOREIGN - EVENT OCCURRED IN FRANCE. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE THE SURGERY DEVICE HAD BLOCKED TURBINE. THERE WAS NO PATIENT IMPACT. ANOTHER ZIMMER BIOMET DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385612 DERMATOME AN HANDPIECE DERMATOME GFD ZIMMER SURGICAL, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1