BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHISTLER MODULAR PEDICLE SCREW SYSTEM

    MDR report key: 15709174 · Received November 1, 2022

    Report

    Report Number
    3012428435-2022-00021
    Event Type
    Malfunction
    Date Received
    November 1, 2022
    Date of Event
    October 3, 2022
    Report Date
    October 28, 2022
    Manufacturer
    EVOLUTION SPINE LLC
    Product Code
    NKB
    UDI-DI
    00195860004685
    PMA / PMN Number
    K182478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CAUSE OF THE MALFUNCTION OF THIS INSTRUMENT COULD BE DUE TO SEVERAL POSSIBILITIES, INCLUDING: THE SURGEON UNINTENTIONALLY INDUCED EXCESSIVE TORQUE ON THE INSTRUMENT BEYOND INTENDED USE CAUSING IT TO EXCEED ITS INTENDED DESIGN STRENGTH AND YIELDING AS A SHEARING FRACTURE OF THE TIP. THE HARDNESS OF THE BONE WAS HIGHER THAN NORMAL REQUIRING THE SURGEON TO APPLY TORQUE BEYOND ITS INTENDED DESIGN STRENGTH AND YIELDING AS A SHEARING FRACTURE OF THE TIP. THE PREPARATION OF THE BONE FOR SCREW INSERTION WAS IMPROPER REQUIRING THE SURGEON TO INTENTIONALLY APPLY TORQUE BEYOND ITS INTENDED DESIGN STRENGTH AND YIELDING AS A SHEARING FRACTURE OF THE TIP. THE INSTRUMENT WAS UNINTENTIONALLY NOT FULLY INSERTED INTO THE SCREW HEAD, RESULTING IN THE TORQUE NOT BEING APPLIED TO THE FULL LENGTH OF THE TIP CAUSING IT TO EXCEED ITS INTENDED DESIGN STRENGTH AND YIELDING AS A SHEARING FRACTURE OF THE TIP. A REVIEW OF THE DHR PAPERWORK, INCLUDING MATERIAL CERTS, REVEALED NOTHING OUT OF THE ORDINARY. THERE WERE NO MANUFACTURING ISSUES WITH WI-003, LOT: 4168. THE RESULTS OF THE INVESTIGATION INDICATE THAT THE CAUSE OF THE FAILURE WAS TORQUE BEYOND THE YIELD STRENGTH OF THE INSTRUMENT. BECAUSE IT IS NOT KNOWN WHETHER THE PATIENT HAD HARD BONE, OR IF THE SURGEON PROPERLY SEATED THE DRIVER INTO THE SCREW THE ACTUAL ROOT CAUSE OF THE BROKEN DRIVER TIP CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    THE SURGEON WAS PERFORMING THE FINAL TIGHTENING OF AN INSERTED PEDICLE SCREW/TULIP WHEN THE TIP OF THE DRIVER BROKE FREE OF THE DRIVER. THE SURGEON LEFT THE BROKEN-OFF TIP IN THE HEAD OF THE PEDICLE SCREW AND INSERTED THE ROD AS PER NORMAL PROCEDURE WHICH SECURED THE BROKEN-OFF TIP IN THE PEDICLE SCREW HEAD, PREVENTING IT FROM MIGRATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639635 WHISTLER MODULAR PEDICLE SCREW SYSTEM PEDICLE SCREW NKB EVOLUTION SPINE LLC WI-003 4168 00195860004685

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Other WC-C, 00195860000014, LOCKING CAP CANNULATED| WC6540-N, 00195860002636, SCREW DIA 6.5 X 40MM| WT55-R, 00195860004654, REDUCTION TULIP, QTY 1