BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INBONE(R) HOLDING TOOL

    MDR report key: 2143400 · Received June 29, 2011

    Report

    Report Number
    1043534-2011-00302
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 24, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HSN
    PMA / PMN Number
    K051023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: USEFUL LIFE EXPECTANCY MET. THE COMPLAINT HISTORY WAS REVIEWED. (B)(4) - TOO DEFORMED TO MEASURE, UNDETERMINED.

    Additional Manufacturer Narrative · 1

    THIS IS A REPORTABLE MALFUNCTION. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ALLEGEDLY TIP OF INSTRUMENT BROKE OFF AND REMAINS IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INBONE(R) HOLDING TOOL SMALL JOINT INSTRUMENT HSN WRIGHT MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1