BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    END CAP INSERTION ROD SLEEVE A3 NAIL

    MDR report key: 5319948 · Received December 22, 2015

    Report

    Report Number
    0008031020-2015-00615
    Event Type
    Malfunction
    Date Received
    December 22, 2015
    Date of Event
    November 20, 2013
    Report Date
    November 21, 2013
    Manufacturer
    STRYKER GMBH
    Product Code
    HSB
    PMA / PMN Number
    K112982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. THE DEVICE IS NOT AVAILABLE TO STRYKER.

    Description of Event or Problem · 1

    THE 900-0026 END CAP INSERTION SLEEVE IS TORN AND MALFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845360 END CAP INSERTION ROD SLEEVE A3 NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER GMBH 3913901

    Patients

    Seq Age Sex Outcome Treatment
    1 Other