BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRASSELER USA MEDICAL, LLC MILING HANDPIECE

    MDR report key: 4317401 · Received November 21, 2014

    Report

    Report Number
    2025102-2014-00004
    Event Type
    Malfunction
    Date Received
    November 21, 2014
    Date of Event
    November 3, 2014
    Report Date
    November 20, 2014
    Manufacturer
    BRASSELER USA, MEDICAL L.L.C.
    Product Code
    HSZ
    PMA / PMN Number
    K935367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE FLAT METAL PLATE ON THE PFJ HANDPIECE THAT THE BURR REST UPON, BROKE DURING USE AS THE DOCTOR WAS BURRING THE ANTERIOR FEMUR DURING A PATELLOFEMORAL ARTHROPLASTY. WHEN THIS HAPPENED, THE BURR RELEASED THE CREATED A DEEPENED GROOVE IN THE PT'S BONE. THIS CAUSED THE PFJ TO BE OVER-BURRED ON THE LATERAL SIDE VS THE MEDIAL SIDE. THE DOCTOR WAS ABLE TO STABILIZE THE COMPONENT WITH CEMENT TO PREVENT THE ORIENTATION TO BE INCORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758492 BRASSELER USA MEDICAL, LLC MILING HANDPIECE SURGICAL MILING HANDPIECE HSZ BRASSELER USA, MEDICAL L.L.C.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR