BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3111902 · Received May 14, 2013

    Report

    Report Number
    1045834-2013-02124
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 16, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MOTOR DEVICE WAS RECEIVED FOR EVALUATION. THE MOTOR DEVICE WAS EVALUATED AND THE REPORTED CONDITION WAS DUPLICATED. EVIDENCE INDICATES THIS WAS DUE TO USAGE WEAR OVER TIME. THE REPORTED CONDITION WAS CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE MOTOR DEVICE¿S ¿HANDPIECE WAS PULLED APART AT THE ELBOW FROM THE HOSE EXPOSING WIRE.¿ THE REPORTER STATED THAT THE DEFICIENCY OCCURRED DURING CLEANING. THERE WERE NO INJURIES REPORTED. THERE WAS NO DELAY IN THE SURGERY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212818 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC-HANDPIECE HOSE HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1