BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3811927 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-06014
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    October 11, 2012
    Report Date
    October 18, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM U.S.A., STATING THAT THE DEVICE WAS LOUD AND VIBRATES. IT IS UNK THAT THE EVENT DID NOT OCCUR DURING SURGERY; IT IS ALSO KNOWN THAT THERE WAS NO PT OR USER INJURY OR MEDICAL INTERVENTION REPORTED RELATED TO THIS OCCURRENCE. NO ADDITIONAL INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524357 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC - HANDPIECE, PRODUCT CODE: HBC HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1