BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATAK SOFT TISSUE ANCHOR

    MDR report key: 2861540 · Received November 28, 2012

    Report

    Report Number
    1822565-2012-02428
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 30, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    KGS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON INSERTED THE ANCHOR INTO THE PT'S HAND, AND THEN NOTICED THERE WAS NO SUTURE ATTACHED TO IT. THE SURGEON REMOVED THE ANCHOR AND FINISHED THE PROCEDURE WITH A NEW ANCHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STATAK SOFT TISSUE ANCHOR SOFT TISSUE ANCHOR KGS ZIMMER, INC. 291338

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR