BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARCO(R) LOCKING SCREW

    MDR report key: 2414293 · Received January 12, 2012

    Report

    Report Number
    1043534-2012-00031
    Event Type
    Malfunction
    Date Received
    January 12, 2012
    Date of Event
    December 5, 2011
    Report Date
    December 8, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HRS
    PMA / PMN Number
    K061808
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A REPORTABLE MALFUNCTION. INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND. AN INVENTORY REVIEW WAS ALSO CONDUCTED. THE PRODUCT WAS DIMENSIONALLY INSPECTED AND PHOTOGRAPHIC IMAGES WERE MADE.

    Description of Event or Problem · 1

    ALLEGEDLY THE SCREW BROKE WHEN THE SURGEON WAS TIGHTENING. ONLY THE SCREW HEAD WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DARCO(R) LOCKING SCREW SMALL JOINT COMPONENT HRS WRIGHT MEDICAL TECHNOLOGY, INC. 1101218615

    Patients

    Seq Age Sex Outcome Treatment
    1