BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3160102 · Received June 10, 2013

    Report

    Report Number
    1045834-2013-02417
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    August 19, 2011
    Manufacturer
    DEPUY SYNTHESE POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES . COMPLAINT OF "HOSE DAMAGE" WAS CONFIRMED DURING THE PRE-REPAIR DIAGNOSTIC ASSESSMENT. THE "EMAX 2 PLUS MOTOR" DID NOT MEET MANUFACTURING SPECIFICATIONS. AFTER REPAIR THE ISSUE WAS RESOLVED. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS.  THE INVESTIGATION IS STILL IN PROCESS.  WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261034 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC, HANDPEICE HBC DEPUY SYNTHESE POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1