BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM CONSOLE

    MDR report key: 3984321 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-16088
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    July 10, 2012
    Report Date
    July 13, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROGRESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE NEEDED TO BE SERVICED. DURING SERVICING, IT WAS FOUND THAT THE DEVICE HAD A DAMAGED COMPONENT - CABLE/CORD/WIRING. IT IS KNOWN THAT THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS KNOWN THAT THERE WAS NO PATIENT OR USER INJURY THAT OCCURRED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664400 SYSTEM CONSOLE HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1