BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM CONSOLE

    MDR report key: 3811816 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-05620
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    January 24, 2011
    Report Date
    January 24, 2011
    Manufacturer
    DEPUY SNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 THE USA STATING THAT THE DEVICE HAD AN ERROR MESSAGE ON THE CONSOLE DURING SURGERY. NO INJURIES WERE REPORTED TO HAVE OCCURRED, HOWEVER, IT IS UNKNOWN IF MEDICAL INTERVENTION WAS NECESSARY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523745 SYSTEM CONSOLE MOTOR, DRILL, ELECTRIC - CONSOLE HBC DEPUY SNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1