BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRASSLER USA MEDICAL, LLC MILLING HANDPIECE

    MDR report key: 4999519 · Received August 11, 2015

    Report

    Report Number
    2025102-2015-00003
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Date of Event
    May 11, 2015
    Report Date
    August 10, 2015
    Manufacturer
    BRASSELER USA, MEDICAL L.L.C.
    Product Code
    HSZ
    PMA / PMN Number
    K935367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION OF THE RETURNED HANDPIECE IDENTIFIED METAL TO METAL GALLING BETWEEN THE MOTOR ASSEMBLY ROTOR AND END PLATES CAUSING MOTOR SEIZURE. EXCEEDING THE RECOMMENDED PSI SETTING AND/OR AGGRESSIVE USE MAY CONTRIBUTE TO THIS CONDITION. INSPECTION OF THE RETURNED HANDPIECE ALSO IDENTIFIED INTERNAL CORROSION, OXIDIZATION, AND CONTAMINATION; THIS INDICATES THE HANDPIECE HAS BEEN IMMERSED OR IMPROPERLY CLEANED. WHEN CLEANING THE HANDPIECE IF ANY FLUIDS (SUCH AS CLEANING AGENTS, PROTEINS, SALINE SOLUTIONS, ETC) ENTER THROUGH THE CONNECTOR OF THE HANDPIECE, IF IMMERSION OCCURS, OR IF THE HANDPIECE IS CLEANED IN A WASHER DISINFECTOR THIS WILL CAUSE A HIGH LEVEL OF CORROSION, OXIDIZATION, AND CONTAMINATION OF THE INTERNAL COMPONENTS CAUSING A LACK OF PERFORMANCE AND EVENTUALLY CAUSING THE HANDPIECE TO NO LONGER FUNCTION. IF A LACK OF PERFORMANCE IS FELT, THIS MAY CAUSE THE USER TO COMPENSATE BY INCREASING OR POSSIBLY EXCEEDING THE MAXIMUM PSI SETTINGS WHICH MAY CAUSE OTHER PROBLEMS INCLUDING METAL TO METAL GALLING BETWEEN THE MOTOR ASSEMBLY ROTOR AND END PLATES CAUSING MOTOR SEIZURE.

    Description of Event or Problem · 1

    THE PFJ HANDPIECE FUNCTIONED IN THE BEGINNING BEFORE IT STARTED TO RESECT BONE. HOWEVER, IN THE MIDDLE OF THE SURGERY, IT SEEMED LIKE THE TORQUE WAS NOT ENOUGH TO CAUSE THE BURR TO REMOVE THE BONE, THEN IT STOPPED MOVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524592 BRASSLER USA MEDICAL, LLC MILLING HANDPIECE HSZ BRASSELER USA, MEDICAL L.L.C. ZIMMER MILL 00-5927-040-00 REV E

    Patients

    Seq Age Sex Outcome Treatment
    1