BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.3MM X 24MM LOCKING CORTICAL SCREW

    MDR report key: 3973252 · Received August 1, 2014

    Report

    Report Number
    3025141-2014-00180
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 2, 2014
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K012655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION SHOWED A SPIRAL FRACTURE PATTERN AT THE SITE OF FAILURE, INDICATING A TORSIONAL FAILURE. INCREASED RESISTANCE OF THE SCREW, RESULTING IN EXCESSIVE TORSIONAL FORCE, CAN BE CAUSED BY MANY CONTRIBUTING FACTORS. THERE IS ADDITIONAL DEFORMATION OF THE SCREW AT THE BREAK THAT APPEARS TO HAVE HAPPENED AFTER THE SCREW BROKE APART WHILE THE SURGEON WAS TRYING TO REMOVE THE SCREW FRAGMENT. NO DEFINITIVE CONCLUSION AS TO THE CAUSE OF THE BREAKAGE CAN BE DRAWN. CONCLUSIONS - A CONCLUSION CANNOT BE DRAWN BASED ON THE LACK OF INFORMATION CONCERNING THE CIRCUMSTANCES OF THIS SCREW BREAKAGE. ADDITIONAL MDRS ASSOCIATED WITH THIS EVENT: MDR 3025141-2014-00181 SCREW 2.

    Description of Event or Problem · 1

    DURING ROUTINE REMOVAL OF THE PLATE AND SCREWS, THE SURGEON FOUND THAT TWO OF THE SCREWS WERE BROKEN. THE SCREWS WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450403 2.3MM X 24MM LOCKING CORTICAL SCREW SCREW, FIXATION, BONE HRS ACUMED LLC CO-T2324-S 287964

    Patients

    Seq Age Sex Outcome Treatment
    1