BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.3MM X 16MM LOCKING CORTICAL SCREW

    MDR report key: 3942301 · Received July 17, 2014

    Report

    Report Number
    3025141-2014-00162
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 20, 2014
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K012655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRIVER THAT WAS USED BY THE DOCTOR IS NOT THE STANDARD PART USED FOR THIS TYPE PLATE. THE DRIVER USED WAS CANNULATED WHILE THE DRIVER THAT IS NORMALLY USED WITH THIS PLATE IS A SOLID DRIVER. THE BROKEN CANNULATED DRIVER HAD A TORSIONAL FRACTURE PATTERN AT THE BREAK WHICH LIKELY INDICATES AN EXCESSIVE TWISTING LOAD. THIS MAY OCCUR WHEN EXCESSIVE FORCE IS APPLIED TO THE DRIVER TO OVERCOME INCREASED RESISTANCE. A SOLID DRIVER WILL BE BETTER ABLE TO WITHSTAND HIGHER TORQUE VALUES THAN THE CANNULATED DRIVER. THE TWO SCREWS WERE STILL THREADED IN THE LOCKING HOLES OF THE PLATE WHEN THE PARTS WERE RECEIVED. USING AN IN-HOUSE DRIVER, THE SCREWS WERE ABLE TO BE UNTHREADED AS DESIGNED. THE LOCKING THREADS ON THE SCREWS AND THE PLATE WERE INTACT AND FUNCTIONED PROPERLY. IN GENERAL, THE PLATE AND SCREWS SHOWED WEAR CONSISTENT WITH BEING IMPLANTED AND THEN BEING REMOVED. THIS INCLUDED BONE GROWTH ON THE THREADS AND HOLES. ADDITIONALLY, THERE WAS DAMAGE TO THE PLATE CONSISTENT WITH TRYING TO PRY IT OFF THE BONE. THE SCREWS WERE DAMAGED AND BENT AND THE HEAD SHOWS SIGNS OF WEAR, ALTHOUGH BOTH STILL FUNCTIONED AS DESIGNED. ADDITIONAL MDRS ASSOCIATED WITH THIS EVENT: MDR 3025141-2014-00159 DRIVER MDR 3025141-2014-00160 PLATE MDR 3025141-2014-00161 SCREW 1

    Description of Event or Problem · 1

    DURING ROUTINE PLATE REMOVAL SURGERY, THE DRIVER TIP BROKE WHEN THE SURGEON WAS TRYING TO REMOVE DISTAL 2.3MM SCREWS. WHEN THE DRIVER TIP BROKE, THE SURGEON BECAME FRUSTRATED AND WOUND UP BREAKING THE BONE WHILE REMOVING THE PLATE WITH TWO SCREWS STILL INSERTED IN THE PLATE. THE BREAK IN THE BONE WAS FILLED WITH BONE GRAFT MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418915 2.3MM X 16MM LOCKING CORTICAL SCREW SCREW, FIXATION, BONE HRS ACUMED LLC CO-T2316 283690

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention