BEUDAMED
    FDA Adverse Event Summary report: N

    OMNITECH CANNULATED COMPRESSION SCREW

    MDR report key: 2484876 · Received March 8, 2012

    Report

    Report Number
    2031009-2012-00001
    Date Received
    March 8, 2012
    Date of Event
    August 7, 2007
    Report Date
    March 7, 2012
    Manufacturer
    TRIMED, INC.
    Product Code
    HRS
    PMA / PMN Number
    K050681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION. DEVICE RETURNED TO MFR. DEVICE WAS REMOVED AND REPLACED WITH A SPARE SCREW.

    Description of Event or Problem · 1

    WHEN INSERTING A 25MM LENGTH 3.0MM CANNULATED COMPRESSION SCREW, THE SURGEON BROKE OFF THE HEAD OF THE SCREW. WHEN INSERTING THE SCREW THAT FAILED, OTHER HARDWARE (SCREWS AND K-WIRES) WERE HOLDING THE FRACTURE IN REDUCTION. THE SURGEON WAS ABLE TO REMOVE THE BROKEN PIECE LODGED IN THE SCAPHOLD USING AN EXTRACTOR. TO SECURE THE FRACTURE, THE SURGEON USED A 3.5MM CANNULATED COMPRESSION SCREW INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNITECH CANNULATED COMPRESSION SCREW 3.0MM CANNULATED COMPRESSION SCREW HRS TRIMED, INC. C3025 AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention