BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3984231 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-03872
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Report Date
    July 22, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. (B)(4).

    Description of Event or Problem · 1

    REPORTER FROM THE US REPORTED HEAT WITH THE DEVICE DURING SURGERY. IT IS KNOWN NO PT/USER INJURY OCCURRED. IT IS UNK IF MEDICAL INTERVENTION HAD OCCURRED. THE OCCURRENCE DATE IS UNK. IF ANY ADD'L INFO SHOULD BECOME AVAILABLE, THIS NOTIFICATION WILL BE UPDATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664423 EMAX 2 PLUS MOTOR HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1 NI