BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUMED 2.3MM X 24MM LOCKING CORTICAL SCREW

    MDR report key: 2853039 · Received September 27, 2012

    Report

    Report Number
    3025141-2012-00082
    Event Type
    Injury
    Date Received
    September 27, 2012
    Date of Event
    May 28, 2012
    Report Date
    August 30, 2012
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K012655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROVIDED X-RAYS WERE REVIEWED AND THE RETURNED PRODUCT WAS VISUALLY EXAMINED UNDER MAGNIFICATION. BASED ON THE X-RAYS IT WAS DETERMINED THAT ONLY 5 SCREWS WERE IMPLANTED IN THE DISTAL PORTION OF THE PLATE WHICH DOES NOT ADHERE TO STEPS 6 AND 7 OF THE SURGICAL TECHNIQUE WHICH STATE THAT A MINIMUM OF 6 SCREWS ARE TO BE USED WITH 2 BEING PLACED IN THE RADIAL STYLOID. IN THIS INCIDENT ONLY ONE SCREW WAS PLACED INTO THE RADIAL STYLOID. THE FOUR BROKEN SCREWS ALL BROKE AT APPROX. THE SAME LOCATION WHERE THE TAPER OF THE SCREW ENDS, WHICH IS ABOUT 5 THREADS FROM THE HEAD OF THE SCREW. THE SCREWS THAT BROKE WERE ALL IN A PARALLEL LINE IN THE PLATE AND WERE PERPENDICULAR TO THE 3.5MM SCREWS. WHILE THE IMPLANTATION PROCESS DID DEVIATE FROM THE SURGICAL TECHNIQUE, IT CANNOT BE DETERMINED IF THIS CAUSED OR CONTRIBUTED TO THE EVENT AS THE POST-OP DETAILS WERE NOT AVAILABLE. THEREFORE NO DEFINITIVE CAUSE CAN BE IDENTIFIED AT THIS TIME. RELATED MDRS: 3025141-2012-00076, 00077, 00078, 00079, 00080, 00081, 00083 AND 00084.

    Description of Event or Problem · 1

    AN ACU-LOC VDR PLATE, STANDARD, LEFT WAS IMPLANTED IN A PT WITH SEVERAL ACUMED SCREWS INCLUDING; ONE 3.5MM X 12MM LOCKING CORTICAL SCREW, ONE 3.5MM X 18.0MM CORTICAL SCREW, ONE 3.5MM X 16.0MM CORTICAL SCREW, ONE 2.3MM X 16MM LOCKING CORTICAL SCREW, AND FOUR 2.3MM X 24MM LOCKING CORTICAL SCREWS. APPROX. FOUR WEEKS POST-OP THE PLATE AND ALL SCREWS WERE REMOVED DUE TO THE FOUR 2.3MM X 24MM LOCKING CORTICAL SCREWS BREAKING. THE TIPS OF THE SCREWS WERE LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUMED 2.3MM X 24MM LOCKING CORTICAL SCREW HRS ACUMED LLC CO-T2324-S 263159

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention