BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 MOTOR

    MDR report key: 3981647 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-16103
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    August 31, 2011
    Report Date
    August 31, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. THIS EVENT WAS PREVIOUSLY REPORTED ERRONEOUSLY UNDER DUPLICATE MFR REPORT # 1045834-2013-04907 ON (B)(6) 2013. PLEASE DISREGARD THAT REPORT. THE REPORT WITH THE SAME MFR REPORT NUMBER AND REFERENCE (B)(4) SENT ON (B)(6) 2013 IS CORRECT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE WOULD NOT SECURE THE CUTTER. THE DEVICE WAS BEING USED IN SURGERY. THERE WAS NO PT OR USER INJURY REPORTED. IT IS UNK IF MEDICAL INTERVENTION OR A DELAY IN SURGERY OCCURRED. THERE IS NO ADDITIONAL INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663710 EMAX 2 MOTOR HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1