BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRASSERLER USA MEDICAL, LLC MILLING HANDPIECE

    MDR report key: 4808093 · Received May 29, 2015

    Report

    Report Number
    2025102-2015-00002
    Event Type
    Malfunction
    Date Received
    May 29, 2015
    Date of Event
    May 6, 2015
    Report Date
    May 28, 2015
    Manufacturer
    BRASSELER USA, MEDICAL L.L.C.
    Product Code
    HSZ
    PMA / PMN Number
    K935367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP: THE HANDPIECE WAS EVALUATED AND WAS IDENTIFIED TO BE IN EXTREMELY POOR CONDITION, SHOWING EXCESSIVE CORROSION AND RUST. THE HANDPIECE WAS SOLD TO CUSTOMER IN (B)(6) OF 2008. THERE IS NO RECORD OF THIS HANDPIECE BEING RETURNED TO BRASSELER FOR SERVICE/PREVENTIVE MAINTENANCE. IT APPEARS THAT THE HANDPIECE HAS NOT RECEIVED ANY PREVENTIVE MAINTENANCE. THE OPERATING INSTRUCTIONS FOR USE RECOMMENDS PREVENTIVE MAINTENANCE EVERY 6 MONTHS. THIS FAILURE IS ATTRIBUTED TO AN EXTENDED LAPSE OF SERVICE/PREVENTIVE MAINTENANCE.

    Description of Event or Problem · 1

    SURGERY WAS BEING DONE AT (B)(6) SURGERY CENTER. PATIENT WAS PREPARED FOR THE PFJ PROCEDURE AND THE INCISIONS WERE MADE. REPRESENTATIVE OPENED DISPOSABLE INSTRUMENTS (SCREWS AND BURR) FOR SURGERY. ATTEMPT WAS MADE TO INSERT BURR INTO HANDPIECE (LOT 08010104) AND IT COULD NOT BE DONE. IT APPEARS THAT A BURR HAD BROKEN OFF IN A PREVIOUS SURGERY. THE BROKEN PIECE CANNOT BE PULLED OUT OF THE HANDPIECE. THE SECOND HAND PIECE (LOT 08010207) WAS BROUGHT OUT TO BE USED. THIS HANDPIECE IS JAMMED AND DOES NOT TURN. PATIENT HAD TO BE CLOSED UP AND MOVED TO (B)(6) HOSPITAL. SURGERY WAS COMPLETED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350039 BRASSERLER USA MEDICAL, LLC MILLING HANDPIECE SURGICAL MILLING HANDPIECE HSZ BRASSELER USA, MEDICAL L.L.C. ZIMMER MILL 00-5927-040-00 REV E

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization