BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF-DRILLING HALF PIN APEX 3MM, 110 X 25MM

    MDR report key: 2191428 · Received July 28, 2011

    Report

    Report Number
    8031020-2011-00169
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    JDW
    PMA / PMN Number
    K861766
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE DOCTOR PLACED 3MM APEX PIN IN TIBIA. THE TIP OF THE PIN BROKE OFF IN FAR CORTICAL BONE. X-RAY TAKEN SHOWS TIP LEFT IN PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELF-DRILLING HALF PIN APEX 3MM, 110 X 25MM IMPLANT JDW STRYKER OSTEOSYNTHESIS SELZACH NA X05253

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other