BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVICTUS SPINAL FIXATION SYSTEM

    MDR report key: 10385438 · Received August 10, 2020

    Report

    Report Number
    2027467-2020-00033
    Event Type
    Injury
    Date Received
    August 10, 2020
    Date of Event
    July 13, 2020
    Report Date
    July 13, 2020
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    HXX
    UDI-DI
    00190376185811
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED INSTRUMENT IS CURRENTLY BEING EVALUATED. A FOLLOW UP REPORT WITH RESULTS OF THE INVESTIGATION WILL BE SUBMITTED UPON COMPLETION.

    Additional Manufacturer Narrative · 0

    AN EVALUATION OF THE RETURNED DRIVER FOUND THAT THE DISTAL TIP HAD FRACTURED AND BECAME SEPARATED FROM THE INSTRUMENT. THE INVICTUS DRIVER PN 17138 IS USED TO FINAL TIGHTEN SET SCREWS UP-TO 110 IN LB WITH USE OF THE INVICTUS TORQUE LIMITING HANDLE PN 17093-110. THE DRIVER IS MANUFACTURED FROM MATERIAL 465 H900 AND HAS A T-27 HEXALOBE AS DEFINED PER PRINT 100448-25 (MINOR LMC 3.40, MAJOR LMC 4.80). THIS HEXALOBE DESIGN IS CONSISTENT WITH PREDICATE ARSENAL FINAL DRIVER PN 87047; SAME MATERIAL AND SIMILAR LMC CONDITIONS (MINOR LMC 3.39, MAJOR LMC 4.79). VISUAL INVESTIGATION REVEALED THAT THE FAILURE IS SHEAR OF THE HEXALOBE. THIS FAILURE OCCURS WHEN THE APPLIED FORCE ON THE INSTRUMENT EXCEEDS THE INSTRUMENT STRENGTH. PER TR-100428, THE ULTIMATE TORQUE FOR THE T-27 HEXALOBE IS DOCUMENTED AS 180.58 +/-0.85 IN-LB; WHICH IS 1.6 SAFETY FACTOR TO THE 110 TIGHTENING TORQUE. THEREFORE, IT IS NOTED THAT FAILURE WAS NOT A RESULT OF THE TIGHTENING TORQUE FROM THE TORQUE LIMITING HANDLE, BUT EXPECTED TO BE DUE TO A NON-TIGHTENING TORQUE LOAD APPLIED DURING USE, WHICH CAN BE A COMBINATION OF HIGH TORQUE COMBINED WITH ADDITIONAL BENDING LOADS (SUCH AS BENDING OF THE INSTRUMENT FROM APPLIED COMPRESSION/DISTRACTION). INVESTIGATION OF LOT# 8307905 INDICATED THE MATERIAL AND MANUFACTURING ARE WITHIN DESIGN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    NO EVALUATION POSSIBLE AT THIS TIME. THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION NOR HAS THE IDENTIFYING LOT NUMBER BEEN PROVIDED. THE DETACHED SECTION WHICH REMAINS ENTRAPPED WITHIN THE IMPLANTED SET SCREW IS APPROXIMATELY 7MM IN LENGTH AND IS MANUFACTURED FROM 465SS (STAINLESS STEEL) AND CERTIFIED TO ASTM A564. THE FINAL DRIVER (17138) IS DESIGN TO BE USED IN CONJUNCTION WITH THE 90 INCH-POUND TORQUE LIMITING T-HANDLE WHICH DELIVERS THE PROPER AMOUNT OF TORQUE TO THE SET SCREWS WITHIN THE INVICTUS POLYAXIAL SCREW. ONCE THE PROPER TORQUE IS ACHIEVED AN AUDIBLE CLICK WILL BE HEARD INDICATING THE SCREWS ARE PROPERLY SEATED AND NO ADDITIONAL TORQUE CAN DELIVERED.

    Description of Event or Problem · 1

    DRIVER TIP BROKE OFF DURING FINAL TIGHTENING. THE DETACHED TIP REMAINS POSITIONED WITHIN THE IMPLANTED SET SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850206 INVICTUS SPINAL FIXATION SYSTEM HXX HXX ALPHATEC SPINE INC 17138 8307905 00190376185811

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other