BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 MOTOR

    MDR report key: 3963972 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-14641
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Report Date
    January 3, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    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 ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. REF: (B)(4).

    Description of Event or Problem · 1

    DEVICE RECEIVED FROM USA FOR SERVICE. DURING SERVICING, IT WAS DISCOVERED THAT THE DEVICE HAD A HOLE OR CUT IN THE HOSE. IT IS UNK IF THE DEVICE WAS USED IN SURGERY. IT IS UNK IF INJURY, SURGICAL DELAY, OR MEDICAL INTERVENTION OCCURRED. THE DATE OF THE EVENT IS UNK. THERE IS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652910 EMAX 2 MOTOR HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1