BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3970005 · Received December 11, 2013

    Report

    Report Number
    1045834-2013-14749
    Event Type
    Malfunction
    Date Received
    December 11, 2013
    Date of Event
    July 21, 2011
    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 Location
    AS
    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 "ERROR MESSAGE" COULD NOT BE CONFIRMED. HOWEVER, DURING SERVICE AND REPAIR, DEVICE FAILURES WERE FOUND, BUT WERE NOT RELATED TO THE REPORTED EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM AUSTRALIA STATING THAT THE DEVICE EXPERIENCED AN "ERROR MESSAGE" DURING SURGERY. THE DEVICE WAS USED DURING SURGERY, BUT NO PATIENT OR USER INJURY OCCURRED. IT IS UNKNOWN IF A DELAY IN THE SURGICAL PROCEDURE OCCURRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648299 EMAX 2 PLUS MOTOR HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1