BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    16CM MIN. INVASIVE ATTACHMENT

    MDR report key: 3811291 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-13971
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    October 21, 2011
    Report Date
    October 21, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE REPORTED CONDITION OF "CANNOT ATTACH TO MOTOR" WAS NOT CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE UNITED STATES INDICATING THAT THE DEVICE "CANNOT BE ATTACHED TO THE MOTOR". IT IS KNOWN THAT THE DEVICE WAS USED IN SURGERY AND THAT NO PATIENT INJURY WAS REPORTED. IT IS UNKNOWN IF MEDICAL INTERVENTION WAS REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523873 16CM MIN. INVASIVE ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1