BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A-CIFT SOLOFUSE

    MDR report key: 8529813 · Received April 18, 2019

    Report

    Report Number
    3005977257-2019-00001
    Event Type
    Malfunction
    Date Received
    April 18, 2019
    Date of Event
    June 19, 2017
    Report Date
    April 18, 2019
    Manufacturer
    SPINEFRONTIER, INC.
    Product Code
    OVE
    PMA / PMN Number
    K131880
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SPINEFRONTIER INVESTIGATION INTO THIS MATTER ESTABLISHES THE ROOT CAUSE OF THE FAILURE RELATED TO DESIGN AND IS NOT RELATED TO MATERIAL, MANUFACTURING, ASSEMBLY, INSPECTION OR SURGICAL SPECIFICATIONS. IN NORMAL USE THE AWL IS IMPACTED WITH A HAMMER AND THE TRAVEL IS LIMITED BY THE END OF THE SLOT HITTING THE SIDE OF THE UNSUPPORTED SCREW. REPEATED IMPACTION THROUGH THE LIFE CYCLE OF THIS INSTRUMENT CAUSES STRESS AND EVENTUALLY A SHEARING FRACTURE OF THE SCREW. VARIABILITY IN MANUAL IMPACT FORCE BY DIFFERENT SURGEONS WOULD CAUSE SOME AWLS TO FAIL WHILE OTHERS MAY NEVER BREAK. ALTHOUGH, THE A-CIFT SOLOFUSE RETRACTABLE AWL RPN VALUES ARE WELL BELOW THE VALUES OBSERVED DURING LIFE VERIFICATION TESTING, SPINEFRONTIER HAS RECOGNIZED THE NEED TO BETTER THE INSTRUMENT DESIGN AND CONSEQUENTLY, AN IMPROVED DESIGN OF THE RETRACTABLE AWL WAS IMPLEMENTED TO MITIGATE THIS OCCURRENCE. THE IMPROVED DESIGN INCLUDES REPLACING THE BUTTON CAP SCREW WITH A PRESS FIT PIN AND LIMITING THE TRAVEL OF THE SLIDING MECHANISM BY STOPPING THE SLIDING ACTION ON THE TAPERED AWL SHAFT AND THE INSIDE OF THE SLEEVE INSTEAD OF THE UNSUPPORTED BUTTON CAP SCREW LIMITING THE SLIDING TRAVEL OF THE ACTUATION AND RECEIVING THE FORCE OF EACH IMPACT.

    Description of Event or Problem · 1

    SPINEFRONTIER RECEIVED INFORMATION FROM INTERNAL AUTHORIZED REPRESENTATIVE STATING THAT THE SLEEVE OF A-CIFT RETRACTABLE AWL WHICH IS USED TO CREATE A PILOT HOLE DISASSEMBLED DURING USE. THE PART WAS SUBSEQUENTLY REMOVED FROM THE SURGICAL SITE, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320875 A-CIFT SOLOFUSE A-CIFT SOLOFUSE OVE SPINEFRONTIER, INC. 11-32106 60347

    Patients

    Seq Age Sex Outcome Treatment
    1