BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3811265 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-14002
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    May 1, 2012
    Report Date
    May 1, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE REPORTED CONDITION OF INTERMITTENT OPERATION COULD NOT BE CONFIRMED. RELIABILITY ENGINEERING EVALUATED THE DEVICE, AND THE REPORTED PROBLEM WAS NOT DUPLICATED BECAUSE THE UNIT PRODUCED AN E8 ERROR AND WOULD NOT OPERATE AT ALL. IT WAS OBSERVED THAT TWO PINS IN THE MOTOR'S CONSOLE CONNECTOR HAD BEEN PUSHED IN, AND THEREFORE THE MOTOR COULD NOT PROPERLY CONNECT TO THE CONSOLE. THIS CONDITION WAS INDICATIVE OF IMPROPER ASSEMBLY / HANDLING OR OF THE DEVICE; THE DAMAGE WAS LIKELY DUE TO NOT ALIGNING THE CONNECTOR PROPERLY BEFORE ATTEMPTING TO CONNECT THE DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. REF# (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM USA STATING THAT THE DEVICE HAS AN "INTERMITTENT OPERATION." THE DEVICE WAS BEING USED DURING SURGERY. NO INJURY OR MEDICAL INTERVENTION OCCURRED. IT IS UNKNOWN IF A DELAY OCCURRED DURING THE SURGICAL PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524003 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC - HANDPIECE HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1