BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYAXIAL DRIVER, REFORM

    MDR report key: 3931393 · Received June 26, 2014

    Report

    Report Number
    3005739886-2014-00031
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    PRECISION SPINE, INC.
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED DRIVER BY ENGINEERING NOTED THAT THE DRIVER FITTING DID NOT SHEAR FLUSH WITH THE SHOULDER OF THE DRIVER. INSTEAD THERE IS A STEP-UP TO THE SHEAR SEVERAL THOUSANDTHS AWAY FROM THE SHOULDER. THIS WOULD INDICATE THAT THE DRIVE SHAFT HAD PARTIALLY COME OUT OF THE BONE SCREW DRIVE FITTING. IT WOULD ONLY BE POSSIBLE FOR THIS TO OCCUR IF THE OUTER SECURE SHAFT HAD COME PARTIALLY UNTHREADED FROM THE TULIP. THE OUTER SECURE SHAFT PUSHES DOWN ON THE CROSS-BAR OF THE DRIVER SHAFT WHEN FULLY THREADED DOWN, WHICH CAUSES THE DRIVER SHOULDER TO BOTTOM-OUT ON THE BONE SCREW. WHEN THIS BOTTOMS-OUT IT CREATES A FRICTION PLATE WITH THE BONE SCREW HEAD AND PROMOTES LOAD SHARING ACROSS THE ENTIRE ASSEMBLY. THE PLASTIC OUTER SLEEVE OF THE ASSEMBLY HAS BEEN MODIFIED TO MITIGATE THE OCCURRENCE OF THE USER UNTHREADING THE OUTER SECURE SHAFT FROM THE TULIP. THIS CHANGE WAS IMPLEMENTED IN (B)(4) AND CONSISTS OF OVERSIZING THE PLASTIC SLEEVE, SO WHEN TIGHTLY GRIPPED BY THE USER THE LOAD WILL NOT BE SO INCLINED AS TO BE TRANSFERRED TO THE OUTER SECURE SHAFT, THUS UNTHREADING THE SECURE SHAFT FROM THE TULIP AND LOOSENING THE DRIVER AND PEDICLE SCREW ASSEMBLY DURING INSERTION. REVIEW OF RECEIVING INSPECTION REPORT FOUND (B)(4) UNITS OF THIS LOT WERE RECEIVED FROM THE SUPPLIER, AND RELEASED FOR DISTRIBUTION ON (B)(4) 2014. A TWO-YEAR COMPLAINT HISTORY REVIEW DID NOT FIND ANY PREVIOUS REPORTS OF THIS NATURE FOR THIS LOT. FURTHER REVIEW FOUND (B)(4) PREVIOUS REPORTS OF THIS NATURE FOR OTHER LOTS MANUFACTURED TO THIS SAME DESIGN REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED ON (B)(6) 2014, THE TIP OF THE REFORM POLYAXIAL DRIVER BROKE WHILE IMPLANTING A 8.5MM X 80MM REFORM PEDICLE SCREW. THE PEDICLE SCREW WAS REMOVED FROM THE PATIENT AND REPLACED, RESULTING IN A DELAY OF APPROXIMATELY FIFTEEN (15) MINUTES. NO PATIENT INJURY WAS REPORTED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DRIVER AVAILABLE IN THE SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372971 POLYAXIAL DRIVER, REFORM SCREWDRIVER HXX PRECISION SPINE, INC. 3155MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention