BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 17361252 · Received July 20, 2023

    Report

    Report Number
    0001526350-2023-00771
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    January 26, 2023
    Report Date
    July 20, 2023
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    UDI-DI
    00889024375901
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER CMP-0861253. G2:FOREIGN: NETHERLANDS. REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE TECH FOUND THAT THE MOTOR SPEED WAS BELOW SPECIFICATION. THE MOTOR WAS REPLACED TO RESOLVE THE REPORTED ISSUE. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OUTSIDE OF SURGERY DURING MAINTENANCE THE DEVICE HAD A DEFECTIVE MOTOR THAT NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT. DURING DEVICE EVALUATION, IT WAS DISCOVERED THAT THE MOTOR SPEED WAS BELOW SPECIFICATION. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. 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
    35322 ZIMMER AIR DERMATOME DERMATOME HANDPIECE, PNEUMATIC GFD ZIMMER SURGICAL, INC. N/A 63415169 00889024375901

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose