BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8CM ANGLE ATTACHMENT

    MDR report key: 3960004 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-14424
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    November 3, 2011
    Report Date
    November 4, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED BY DEPUY SYNTHES POWER TOOLS. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL MDR WILL BE SENT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM U.S.A. STATING THAT THE DEVICE WAS HEATING UP. IT IS KNOWN THAT THE EVENT OCCURRED DURING SURGERY. THERE WAS NO PT OR USER INJURY. IT IS UNK IF THERE WAS ANY MEDICAL INTERVENTION THAT OCCURRED. NO ADDITIONAL INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654425 8CM ANGLE ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1