BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYAXIAL DRIVER, REFORM

    MDR report key: 3922458 · Received June 3, 2014

    Report

    Report Number
    3005739886-2014-00029
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    PRECISION SPINE, INC.
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PROBLEM ALREADY KNOWN, NO EVALUATION NECESSARY. METHOD: THE ACTUAL DEVICE INVOLVED IN THIS INCIDENT WAS NOT EVALUATED AS THE FAILURE WAS ALREADY A KNOWN FAILURE AND CORRECTIVE ACTIONS HAVE BEEN INITIATED. CONCLUSION: PREVIOUS EVALUATION IDENTIFIED THAT ALTHOUGH THE EXACT ROOT CAUSE COULD NOT BE CONFIRMED, IT IS POSSIBLE THAT THE DRIVER MAY NOT HAVE BEEN COMPLETELY SECURED INTO THE PEDICLE SCREW. THIS WOULD MINIMIZE THE AMOUNT OF LOAD-SHARING INHERENT IN THE DESIGN. IN EFFORT TO PREVENT RECURRENCE OF ISSUES OF THIS NATURE A DRIVER TIP CHANGE WAS INITIATED TO RELIEVE INHERENT STRESS RISERS IN THE DRIVER TIP. IN ADDITION, THE PLASTIC OUTER SLEEVE OF THE ASSEMBLY HAS BEEN MODIFIED TO MITIGATE THE OCCURRENCE OF THE USER UNINTENTIONALLY UNTHREADING THE OUTER SECURE SHAFT FROM THE TULIP. THIS CHANGE CONSISTS OF OVER SIZING 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED ON (B)(6) 2104, THE TIP OF THE REFORM POLYAXIAL DRIVER BROKE. THE BROKEN PIECE WAS RETRIEVED FROM THE HEAD OF THE SCREW AND THE PROCEDURE WAS COMPLETE WITH A SECOND DRIVER THAT WAS READILY AVAILABLE. NO PT INJURY OR DELAY TO THE PROCEDURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323294 POLYAXIAL DRIVER, REFORM SCREWDRIVER HXX PRECISION SPINE, INC. 3055MMR

    Patients

    Seq Age Sex Outcome Treatment
    1