BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    END CAP T2 HUMERUS 6MM, 5MM HEIGHT

    MDR report key: 2917760 · Received December 18, 2012

    Report

    Report Number
    9610622-2012-00582
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K011529
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADD'L DEVICE: HUMERAL NAIL, 1830-1922S; AP T2 HUMERUS 9X220MM, LOT # K127581.

    Description of Event or Problem · 1

    DURING T2 HUMERUS NAIL EXTRACT SURGERY, THE SURGEON USES THE DRIVER AND TRIED TO REMOVE THE END CAP. WHEN THE SURGEON TURNED THE DRIVER, THE THREAD PART OF END CAP BROKE. THEREFORE, THE SURGEON REMOVED THE THREAD PART OF END CAP WHICH REMAINED IN THE NAIL AND THE OPERATION WAS FINISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 END CAP T2 HUMERUS 6MM, 5MM HEIGHT IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K274163

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other