BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE, ELECTRIC DERMATOME

    MDR report key: 17511651 · Received August 11, 2023

    Report

    Report Number
    0001526350-2023-00898
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Report Date
    August 10, 2023
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED AS AN INITIAL / FINAL REPORT BASED ON INFORMATION DISCOVERED DURING THE DEVICE EVALUATION. REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE RPMS WERE OUT OF SPECIFICATION ON THE HIGH END AND THE CALIBRATION WAS OUT AT THE ZERO READING. THE MOTOR, ECCENTRIC SHAFT, PLUG HARNESS, SWITCH, SPRING SEAL, VESPEL AND SEMI-CIRCLE BEARINGS AND VARIOUS OTHER PARTS WERE REPLACED AND RESOLVED 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 A DEVICE RETURNED FOR MAINTENANCE AND REQUIRED REPAIR. THE EVALUATION DETERMINED THE RPMS WERE OUT OF SPECIFICATION ON THE HIGH END. THE CONTROL BAR WAS IN THE CORRECT POSITION. THE CALIBRATION WAS OUT AT THE 0 READING. THERE WAS NO EVENT AS THE DEVICE ONLY RETURNED FOR MAINTENANCE. THERE WAS NO REPORTED PATIENT HARM, OR DELAY. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595168 HANDPIECE, ELECTRIC DERMATOME DERMATOME HANDPIECE, ELECTRICALLY-POWERED GFD ZIMMER SURGICAL, INC. N/A 62476758

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose