BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3963949 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-14829
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    June 1, 2011
    Report Date
    June 20, 2011
    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
    OTHER

    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

    REPORT RECEIVED FROM USA STATING THAT THE DEVICE WAS EXPERIENCING HEATING ISSUES. THE DEVICE WAS BEING USED DURING SURGERY. THERE WAS NO PT OR USER INJURY REPORTED. IT IS UNK IF SURGICAL DELAY OR MEDICAL INTERVENTION OCCURRED. THE EVENT OCCURRED DURING JUNE 2011, HOWEVER, THE EXACT CAUSE OF THE EVENT IS UNK. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652630 EMAX 2 PLUS MOTOR HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1