BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0 CM SHORT ATTACHMENT

    MDR report key: 3130511 · Received May 24, 2013

    Report

    Report Number
    1045834-2013-02204
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 16, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTACHMENT DEVICE WAS RECEIVED FOR EVALUATION. THE ATTACHMENT DEVICE WAS EVALUATED AND THE REPORTED CONDITION WAS NOT DUPLICATED. THE REPORTED CONDITION WAS NOT 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 AN ATTACHMENT DEVICE IN WHICH, DURING ROUTINE EVALUATION, IT WAS DISCOVERED THAT THE DEVICE WAS "HEATING UP AND LOSING POWER". THE ATTACHEMENT 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
    231126 5.0 CM SHORT ATTACHMENT MOTOR, DRILL, ELECTRIC-ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1