BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3955284 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-14736
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    January 10, 2012
    Report Date
    January 11, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY SYNTHES POWER TOOLS.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT SERVICE WAS REQUIRED FOR THE DEVICE. DURING SERVICE A BROKEN DRIVE SHAFT WAS NOTED. THE DEVICE WAS BEING USED DURING SURGERY. NO INJURY OCCURRED. 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
    653999 EMAX 2 PLUS MOTOR HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1