BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0 CM SHORT ATTACHMENT

    MDR report key: 3160056 · Received June 10, 2013

    Report

    Report Number
    1045834-2013-02418
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    DEPUY SYNTHES
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM U.S.A. STATING THAT THE DEVICE (ATTACHMENT) COULD NOT ATTACH TO THE MOTOR. THIS DEVICE WAS NOT USED IN SURGERY. IT IS UNKNOWN IF THERE WAS ANY USER OR PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, THIS NOTIFICATION WILL BE UPDATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260735 5.0 CM SHORT ATTACHMENT MOTOR, DRILL, ELECTRIC ATTACHMENT HBC DEPUY SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1