BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3170591 · Received June 14, 2013

    Report

    Report Number
    1045834-2013-02465
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 22, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS BEEN RETURNED. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE WIRING WAS EXPOSED DUE TO HOSE / CORD BEING TORN / PULLED AWAY FROM THE MOTOR. EVIDENCE SUGGESTS THIS WAS DUE TO MISHANDLING DURING THE CLEANING PROCEDURE. 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 "THE CORD WAS PULLED OUT OF THE BACK OF THE HAND PIECE" DEVICE AND "THE WIRES WERE EXPOSED". IT WAS UNKNOWN IF THE DEVICE WAS BEING USED IN A SURGICAL PROCEDURE OR IF MEDICAL INTERVENTION WAS REQUIRED. IT WAS UNKNOWN TO THE REPORTER IF THERE WAS A DELAY TO A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS ALLEGED. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271343 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC - HAND PIECE HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1