BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX2PLUS_LL

    MDR report key: 3811300 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-13326
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    December 21, 2011
    Report Date
    December 21, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE REPORTED COMPLAINT OF "OVERHEATING" WAS NOT CONFIRMED. TEMPERATURE TESTING WAS WITHIN ACCEPTABLE LIMITS. IF ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM USA, STATING THAT THE DEVICE WAS OVERHEATING. IT IS KNOWN THAT THE EVENT OCCURRED DURING SURGERY. THERE WAS NO PT OR USER INJURY; HOWEVER, IT IS UNK IF THERE WAS SURGICAL DELAY OR MEDICAL INTERVENTION REPORTED RELATED TO THIS OCCURRENCE. NO ADD'L INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523875 EMAX2PLUS_LL MOTOR, DRILL, ELECTRIC - HANDPIECE HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1