BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 MOTOR

    MDR report key: 3984142 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-16387
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    October 17, 2011
    Report Date
    October 17, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 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).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE "WOULD NOT SECURE ATTACHMENT: DURING SURGERY. IT IS KNOWN THAT DEVICE WAS BEING USED DURING SURGERY BUT NO PATIENT OR USER INJURY OCCURRED. IT IS UNKNOWN IF A DELAY IN THE SURGICAL PROCEDURE OR SURGICAL INTERVENTION OCCURRED AS A RESULT OF THE DEVICE ISSUE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663278 EMAX 2 MOTOR HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1