BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3963932 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-12155
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE REPORTED CONDITION OF "OVERHEATING" COULD NOT BE CONFIRMED. THE DEVICE PASSED ALL TESTS AND NO PROBLEMS WERE OBSERVED. IF ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM USA STATING THAT THE DEVICE WAS OVERHEATING. THE DEVICE WAS USED IN SURGERY. THERE WAS NO PT OR USER INJURY REPORTED. IT IS UNK IF SURGICAL DELAY OR MEDICAL INTERVENTION OCCURRED. THERE IS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652980 EMAX 2 PLUS MOTOR HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1