BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 MOTOR

    MDR report key: 3130497 · Received May 24, 2013

    Report

    Report Number
    1045834-2013-02205
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MOTOR DEVICE WAS RECEIVED FOR EVALUATION. THE MOTOR DEVICE WAS TESTED AND THE REPORTED CONDITION WAS DUPLICATED. EVIDENCE INDICATED THIS WAS DUE TO USAGE WEAR OVER TIME. THE REPORTED CONDITION WAS CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA REGARDING A MOTOR DEVICE IN WHICH, DURING ROUTINE MAINTENANCE, IT WAS DISCOVERED THAT THE DEVICE WAS "RUNNING HOT TO THE TOUCH". THE MOTOR DEVICE WAS NOT USED IN SURGERY. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232647 EMAX 2 MOTOR MOTOR, DRILL, ELECTRIC- HANDPIECE HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1