BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANSSON PIN TI 75MM

    MDR report key: 1981644 · Received January 12, 2011

    Report

    Report Number
    8031020-2011-00003
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 16, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    JDW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING SURGERY, THE SURGEON TRIED TO TURN THE T-HANDLE TO PUSH OUT THE HOOK. HOWEVER, THE HOOK WAS NOT ABLE TO BE PUSHED OUT FROM THE TIP OF OUTER PIN. THEREFORE, THE SURGEON CHANGED THE PIN TO ANOTHER NEW PIN AND THE SURGERY WAS COMPLETED WITH A NEW PIN. BECAUSE THE DEVICE FUNCTIONED BY HAVING CHANGED THE PIN TO ANOTHER NEW PIN, THE SURGEON THINKS THAT THERE WAS A PROBLEM IN THE PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANSSON PIN TI 75MM IMPLANT JDW STRYKER OSTEOSYNTHESIS SELZACH NA T99301

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other