BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 MOTOR

    MDR report key: 3962867 · Received June 13, 2014

    Report

    Report Number
    1045834-2013-16459
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED, AND DURING SERVICE IT WAS FOUND THAT THE DEVICE WAS MAKING AN UNUSUAL NOISE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT SERVICE WAS REQUIRED FOR THE DEVICE. DURING SERVICE NOISE WAS NOTED. IT IS UNKNOWN IF THE DEVICE WAS USED IN SURGERY OR IF INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350826 EMAX 2 MOTOR ELECTRIC SURGICAL DRILL HBC

    Patients

    Seq Age Sex Outcome Treatment
    1