BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE EMAX 2 PLUS SYSTEM

    MDR report key: 4133157 · Received October 1, 2014

    Report

    Report Number
    1045834-2014-13199
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    March 21, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, INVESTIGATION REVEALED DEVICE CONTINUOUSLY RUNS WHICH CAUSES IT TO OVERHEAT. THE DEVICE WAS REPAIRED AND RETURNED TO CUSTOMER ON 3/25/2013.

    Description of Event or Problem · 1

    CUSTOMER REPORTED EMISSION OF HEAT AND DEFECT IN ROTATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611138 THE EMAX 2 PLUS SYSTEM MOTOR, DRILL, ELECTRIC HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1