BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0CM SHORT ATTACHMENT

    MDR report key: 3111945 · Received May 14, 2013

    Report

    Report Number
    1045834-2013-02126
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 15, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTACHMENT DEVICE WAS RECEIVED FOR EVALUATION. THE ATTACHMENT DEVICE WAS EVALUATED AND DID NOT EXCEED TEMPERATURE LIMITS. THE REPORTED CONDITION COULD NOT BE DUPLICATED THEREFORE 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 1 OF 2 FOR THE SAME EVENT. REPORT RECEIVED FROM THE USA STATING THAT DURING A COCHLEAR IMPLANT SURGERY THE MOTOR DEVICE AND THE ATTACHMENT DEVICE "HEATED UP." THERE WAS NO DELAY REPORTED IN SURGERY. THERE WAS A SPARE IDENTICAL DEVICE AVAILABLE FOR USE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REQUIRED.THOUGH REQUESTED, PATIENT INFORMATION WOULD NOT BE DISCLOSED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213134 5.0CM SHORT ATTACHMENT MOTOR, DRILL, ELECTRIC_ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1