BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKMAX-NEURO

    MDR report key: 3811907 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-05029
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    July 31, 2012
    Report Date
    July 31, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBB
    PMA / PMN Number
    K831756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE'S HOSE WAS LEAKING AIR. THE DEVICE WAS BEING USED DURING SURGERY. NO INJURY OR MEDICAL INTERVENTION OCCURRED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523802 BLACKMAX-NEURO MOTOR, DRILL, PNEUMATIC - HANDPIECE HBB DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1