BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, ELECTRIC DERMATOME

    MDR report key: 15658410 · Received October 24, 2022

    Report

    Report Number
    0001526350-2022-01025
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Date of Event
    October 13, 2022
    Report Date
    February 21, 2023
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    UDI-DI
    00889024375994
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER: (B)(4). REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE UNIT WAS OUT OF CALIBRATION AT THE 0 READING. THE FIND ADJUSTMENT CAMS, VESPEL BEARINGS, SEMI-CIRCLE BEARINGS, NEEDLE BEARING, AND SPRING SEAL WERE REPLACED TO RESOLVE THE REPORTED ISSUE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. 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 LOOSE GEARING/RETENTION CLIP. THERE WAS NO HARM OR DELAY REPORTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION

    Description of Event or Problem · 0

    THERE IS NO ADDITIONAL EVENT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2148395 HANDPIECE, ELECTRIC DERMATOME DERMATOME, LINE-POWERED GFD ZIMMER SURGICAL, INC. N/A 65057363 00889024375994

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown