BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKMAX-NEURO

    MDR report key: 3162994 · Received June 11, 2013

    Report

    Report Number
    1045834-2013-02437
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    January 7, 2011
    Report Date
    January 14, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HSZ
    PMA / PMN Number
    K831756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY (B)(4). THE INVESTIGATION IS STILL IN PROCESS.  WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE WAS EXPERIENCING "LOW POWER". THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNKNOWN IF THERE WAS PATIENT/USER INJURY OR MEDICAL INTERVENTION. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262220 BLACKMAX-NEURO INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED - HANDPIECE HSZ DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1