BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKMAX-NEURO LOW PRESSURE

    MDR report key: 3811922 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-06658
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    November 22, 2010
    Report Date
    January 12, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBB
    PMA / PMN Number
    K831756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES. THE DEVICE IS CURRENTLY UNDERGOING EVAL. ONCE THE EVAL HAS BEEN COMPLETED OR IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT THERE IS "OIL LEAKING FROM THE LOCK LEVER, AND CUTTER INSERTION PART". THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNK IF INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523813 BLACKMAX-NEURO LOW PRESSURE MOTOR, DRILL, PNEUMATIC - HANDPIECE, PRODUCT CODE: HBB HBB DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1