BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3124007 · Received May 22, 2013

    Report

    Report Number
    1045834-2013-02167
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    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 MOTOR DEVICE WAS RECEIVED FOR EVALUATION. THE ATTACHMENT DEVICE WAS TESTED AND FAILED SOUND SPECIFICATION. EVIDENCE INDICATED THIS WAS DUE INTERNAL MOTOR FAILURE DUE TO EXCESSIVE FORCE. THE REPORTED CONDITION WAS CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA REGARDING A MOTOR DEVICE IN WHICH, DURING A ROUTINE INSPECTION, IT WAS DISCOVERED THAT THE DEVICE WAS RUNNING LOUDER THAN USUAL. THE DEVICE WAS NOT USED IN SURGERY. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225890 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC- HANDPIECE HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1