BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3113181 · Received May 9, 2013

    Report

    Report Number
    1045834-2013-02113
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    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

    THE MOTOR DEVICE WAS NOT REC'D FOR EVAL. IF ADD'L INFO IS REC'D, A SUPPLEMENTAL REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE FAILED TEMPERATURE SPECIFICATIONS. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. EVIDENCE SUGGESTS THIS WAS DUE TO A FAILURE OF THE INTERNAL MOTOR OR MECHANICAL COMPONENTS DUE TO EXCESSIVE FORCE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT REC'D FROM THE USA STATING THAT DURING PRE-CHECK, IT WAS DISCOVERED THAT THE MOTOR DEVICE WAS "OVERHEATING." THERE WERE NO DELAYS TO SURGERY AS AN IDENTICAL SPARE MOTOR DEVICE WAS AVAILABLE. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202718 EMAX 2 PLUS MOTOR HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1