BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2843619 · Received October 25, 2012

    Report

    Report Number
    8031020-2012-00259
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    March 30, 2012
    Report Date
    October 8, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    JDW
    PMA / PMN Number
    K861766
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN IF THE DEVICE WILL BE RETURNED FOR EVAL. IF THE DEVICE OR ADDITIONAL INFO BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, WHILE INSERTING PINS INTO TIBIA, THE TIP BROKE OFF. THE SURGEON IS AWARE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other