BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSOLE,EMAX 2(CONVERTED) W/IRR

    MDR report key: 3222206 · Received July 12, 2013

    Report

    Report Number
    1045834-2013-02725
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 20, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. THE REPORTED CONDITION WAS CONFIRMED AND DUPLICATED. EVIDENCE INDICATES THIS WAS DUE TO USAGE WEAR OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CONSOLE DEVICE "GAVE AN ERROR MESSAGE (CODE UNKNOWN)" AND WAS MAKING A "REALLY BAD NOISE." IT WAS UNKNOWN TO THE REPORTER IF THE DEVICE WAS USED IN SURGERY. IT WAS UNKNOWN TO THE REPORTER IF THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITHOUT DELAY OR IF AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS UNKNOWN IF THERE WAS 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
    324195 CONSOLE,EMAX 2(CONVERTED) W/IRR MOTOR, DRILL, ELECTRIC-CONSOLE HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1