BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3984191 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-15892
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    December 5, 2011
    Report Date
    February 2, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED BY DEPUY SYNTHES POWER TOOLS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT FROM THE USA STATING THAT THE DEVICE HAD AN ISSUE WITH HEAT, NOISE, AND SMOKE DURING MOTOR ROTATION. THE DEVICE WAS USED IN SURGERY AND THERE WERE NO INJURIES REPORTED. NO ADDITIONAL INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664408 NA NA N/A DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1