BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 3984269 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-16081
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Report Date
    July 20, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT.

    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 DAMAGED COMPONENTS - LOCKING MECHANISM NOT FUNCTIONING. IT IS UNK IF THE DEVICE WAS BEING USED DURING SURGERY. IT IS UNK IF THERE WAS USER OR PT INJURY. THE DATE OF THE EVENT IS UNK. THERE WAS O ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663859 XMAX MOTOR ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1