BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKMAX-NEURO

    MDR report key: 3811223 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-13833
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Report Date
    June 26, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBB
    PMA / PMN Number
    K831756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REC'D BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT REC'D FROM THE USA STATING THAT THE DEVICE HAD HOSE DAMAGE. THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNK IF INJURY OR MEDICAL INTERVENTION WERE REPORTED. THE DATE OF THE EVENT IS UNK. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523905 BLACKMAX-NEURO MOTOR, DRILL, PNEUMATIC - HANDPIECE, PRODUCT CODE: HBB HBB DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1