BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKMAX-NEURO

    MDR report key: 4201185 · Received October 27, 2014

    Report

    Report Number
    1045834-2014-14624
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Report Date
    October 1, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBB
    PMA / PMN Number
    PK831756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS NOT CONFIRMED. THEREFORE, AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT THE MOTOR DEVICE HAD NO POWER AND WAS MAKING WEIRD NOISE. IT WAS NOT REPORTED THAT THE EVENT OCCURRED DURING SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681635 BLACKMAX-NEURO MOTOR, DRILL, PNEUMATIC - HANDPIECE HBB DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1