BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE EMAX 2 PLUS SYSTEM

    MDR report key: 4120879 · Received September 26, 2014

    Report

    Report Number
    1045834-2014-13055
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    January 15, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, INVESTIGATION REVEALED THE DEVICE HOUSING WAS DAMAGED AND THE HOSE WAS MISSING THE PLUG. THERE WAS NO EVIDENCE OF DEVICE OVERHEATING DURING THE INVESTIGATION. THE DEVICE WAS REPAIRED AND RETURNED TO CUSTOMER ON (B)(4) 2013. MFR DATE: 8/29/2011.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE DEVICE OVERHEATS AFTER 3-5 MINUTES AND MAKES EXCESSIVE NOISE. THIS IS REPORT 1 OF 1 FOR #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601994 THE EMAX 2 PLUS SYSTEM MOTOR, DRILL, ELECTRIC HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1