BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3241318 · Received July 22, 2013

    Report

    Report Number
    1045834-2013-03610
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 25, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. THE DEVICE PASSED ALL OPERATIONAL SPECIFICATIONS, THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE THERE WAS AN "E9 ERROR ON THE MOTOR DEVICE". THERE WAS NO DELAY TO THE PLANNED SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS ALLEGED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340306 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC - HAND PEICE HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1