BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANSSON PIN TI 80MM

    MDR report key: 1884556 · Received October 21, 2010

    Report

    Report Number
    8031020-2010-00138
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 4, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    KTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING HANSSON PIN SURGERY, THE SURGEON OPENED THE OUTER PACKAGE OF THE PIN, AND FOUND THAT THE BLISTER PACK WAS DEFORMED. THE SURGEON FELT THAT THE STERILITY MAY HAVE BEEN COMPROMISED. HE CHANGED THE PIN TO A NEW PIN OF THE SAME SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANSSON PIN TI 80MM IMPLANT KTT STRYKER OSTEOSYNTHESIS SELZACH NA T106973

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other