BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, ELECTRIC DERMATOME

    MDR report key: 21834563 · Received April 14, 2025

    Report

    Report Number
    0001526350-2025-00478
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    March 28, 2025
    Report Date
    September 30, 2025
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). A FOLLOW UP/ FINAL REPORT WILL BE SUBMITTED ONCE INVESTIGATION IS COMPLETE. G2: FOREIGN COUNTRY - NETHERLANDS.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). FOLLOWING SECTIONS WERE UPDATED OR CORRECTED: B4, B5, D4, D9, G3, G6, H2, H3, H4, H6 AND H11. REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE DEVICE WOULD NOT POWER ON; CABLE CONTACT ISSUE AND CORRODED MOTOR. THE MOTOR AND PLUG HARNESS ASSEMBLY WERE REPLACED AND RESOLVED THE REPORTED ISSUE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO COMPONENT FAILURE AS THE DEVICE EXHIBITS WEAR AND TEAR FROM REPEATED USE. THE EVENT IS CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DERMATOME STARTS TO TURN SLOWER AND SLOWER. THE DERMATOME THEN BECOMES TOO HOT DURING PROLONGED USE. THE EVENT TIMING WAS OUTSIDE OF SURGERY. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM AND DELAY REPORTED. DUE DILIGENCE IS COMPLETE.

    Description of Event or Problem · 0

    THERE WAS NO ADDITIONAL INFORMATION ASSOCIATED WITH THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2269164 HANDPIECE, ELECTRIC DERMATOME DERMATOME FZQ ZIMMER SURGICAL, INC. 62587639

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown