BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKMAX-NEURO

    MDR report key: 3111876 · Received May 7, 2013

    Report

    Report Number
    1045834-2013-02093
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 8, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HSZ
    PMA / PMN Number
    K831756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MOTOR DEVICE WAS REC'D FOR EVAL. THE MOTOR DEVICE WAS TESTED AND THE REPORTED CONDITION WAS DUPLICATED. EVIDENCE INDICATED THIS WAS DUE TO USAGE WEAR OVER TIME. THE REPORTED CONDITION WAS CONFIRMED. IF ADD'L INFO IS REC'D, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2. REPORT REC'D FROM THE USA STATING THAT AN AIR LEAK WAS OBSERVED BETWEEN THE "HOSE AND THE HAND PIECE" ON THE MOTOR DEVICE. AN IDENTICAL SPARE MOTOR DEVICE WAS AVAILABLE FOR USE. THERE WAS NO PT INVOLVEMENT. NO INJURIES WERE REPORTED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198037 BLACKMAX-NEURO HSZ DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1