BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NON-LOCKING SCREW ANCHORAGE ?3.0NN/L20MM

    MDR report key: 2850947 · Received November 20, 2012

    Report

    Report Number
    8031020-2012-00286
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 13, 2012
    Manufacturer
    STRYKER TRAUMA AG
    Product Code
    HRS
    PMA / PMN Number
    K083447
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED FOR EVAL. IF THE DEVICE OR ADD¿L INFO BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS PUTTING IN AN ANCHORAGE PLATE FOR A TARSAL METATARSAL FUSION ON PT¿S RIGHT SIDE. WHILE TIGHTENING A NON LOCKING COMPRESSION SCREW, THE HEAD OF THE SCREW BROKE OFF. SCREW HEAD WAS EXTRACTED WITHOUT ANY CONSEQUENCE AND BALANCE OF SCREW SHAFT/THREADS WERE SECURELY ANCHORED IN THE BONE SO SURGEON DID NOT ATTEMPT TO REMOVE AND THEREFORE REMAINED IN PT IN THE COMPRESSION HOLE. THERE WAS NO DELAY IN SURGERY OR ADVERSE CONSEQUENCE TO THE PT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON-LOCKING SCREW ANCHORAGE ?3.0NN/L20MM IMPLANT HRS STRYKER TRAUMA AG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other