BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 MOTOR

    MDR report key: 3981604 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-15921
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Report Date
    May 22, 2006
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED BY DEPUY SYNTHES. ONCE THE DEVICE IS RECEIVED AND THE EVALUATION HAS BEEN COMPLETED OR IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL MDR WILL BE SENT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT "THE MOTOR IS OFTEN SET ASIDE AND THAT THE DOCTOR FEELS THAT THE RISK OF INADVERTENTLY ACTUATION WHILE THE MOTOR IS SITTING UNUSED, BUT STILL NEAR THE SURGICAL SITE." IT IS UNK IF THE DEVICE WAS BEING USED IN SURGERY AND IF INJURY OR MEDICAL INTERVENTION OCCURRED. THE DATE OF EVENT IS UNK. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663662 EMAX 2 MOTOR HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1