BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE EMAX 2 PLUS SYSTEM

    MDR report key: 4180595 · Received October 17, 2014

    Report

    Report Number
    1045834-2014-13337
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    November 20, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE DEVICE SHOWED SIGNS OF WATER DAMAGE AND WAS NOT FUNCTIONING PROPERLY. THIS WAS ATTRIBUTED TO IMPROPER MAINTENANCE OF THE DEVICE. DEVICE WAS REPLACED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED FOR AN UNKNOWN REASON. DURING SERVICE, TECHNICIAN FOUND THAT HOSE WAS DAMAGED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663172 THE EMAX 2 PLUS SYSTEM MOTOR, DRILL, ELECTRIC HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1