BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTEX PEDICLE SCREW SYSTEM

    MDR report key: 12050414 · Received June 23, 2021

    Report

    Report Number
    3005031160-2021-00012
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 24, 2021
    Report Date
    June 23, 2021
    Manufacturer
    XTANT MEDICAL
    Product Code
    MNH
    UDI-DI
    M697X02202401
    PMA / PMN Number
    K120832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT THE COMPANY, THE CONDITION OF THE RETURNED SYSTEM SCREWDRIVER THREADING WAS IDENTIFIED AS BROKEN, NOT WORN AS REPORTED. THE COMPANY'S REGULATORY REPORTING ASSESSMENT WAS UPDATED AS APPROPRIATE FOR AN INSTRUMENT MALFUNCTION THAT OCCURRED DURING A SURGICAL PROCEDURE. A VISUAL ASSESSMENT OF THE RETURNED SYSTEM SCREWDRIVER SHOWED AN INSTRUMENT WITH REPEATED USE, AS IDENTIFIED BY WORN LASER MARKINGS AND SURFACE SCRATCHES. THE TIN COATING AT THE DISTAL TIP OF THE INSTRUMENT WAS WORN AND THE HEX TIP WAS ROUNDED. A SMALL PORTION OF THE LEADING SQUARE THREAD DETAIL WAS SEPARATED FROM THE SLEEVE OF THE INSTRUMENT BUT PRESENT. A FUNCTIONALITY ASSESSMENT WAS NOT PERFORMED DUE TO THE DAMAGED CONDITION OF THE RETURNED COMPLAINT INSTRUMENT, WHICH WAS REMOVED FROM DISTRIBUTABLE INVENTORY. A DHR REVIEW WAS PERFORMED FOR THE COMPLAINT DEVICE LOT AND THERE WERE NO RELEVANT MANUFACTURING ANOMALIES IDENTIFIED. THE DEVICE LOT MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. THIS LOT HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 11/27/2012. THE SQUARE THREAD DETAIL OF THE SYSTEM SCREWDRIVER COULD BECOME DAMAGED IF THE USER OVER-TORQUED THE HANDLE ATTACHED TO THE DRIVER WHILE NOT IN THE NEUTRAL POSITION OR IF THE PEDICLE SCREW WAS NOT PROPERLY LOADED ONTO THE DRIVER. PER THE SYSTEM SURGICAL TECHNIQUE GUIDE, "IF THE RATCHETING SCREWDRIVER HANDLE (ATTACHED TO THE PROXIMAL END OF THE PEDICLE SCREWDRIVER AT THIS STEP IN THE TECHNIQUE) IS NOT PLACED IN THE NEUTRAL, NON-RATCHETING POSITION FOR SCREW DISENGAGEMENT, THE (PEDICLE SCREW) DRIVER MAY BE DIFFICULT TO DISENGAGE FROM THE SCREW." THERE IS AN ADDITIONAL NOTE PRESENT IN THE SYSTEM SURGICAL TECHNIQUE GUIDE THAT STATES, "IF THE USER TURNS THE DRIVER WITH HIGH TORQUE FORCE WITHOUT PLACING THE HANDLE IN THE NEUTRAL POSITION, THIS COULD CAUSE CONSIDERABLE DAMAGE TO THE THREADS INCLUDED CAUSING THEM TO BREAK OFF COMPLETELY." PROPER PEDICLE SCREW LOADING PREVENTS SCREW TOGGLE WHILE UNDER LATERAL FORCES. IF THE PEDICLE SCREW IS NOT LOADED ONTO THE DRIVER CORRECTLY, THE LATERAL FORCES ARE TRANSFERRED TO THE SQUARE THREAD DETAIL AND MAY RESULT IN AN INSTRUMENT MALFUNCTION. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE RELIABLY DETERMINED. THERE HAVE NOT BEEN ANY OTHER COMPLAINTS OF SIMILAR NATURE IN THE PAST 12 MONTHS. THE COMPANY WILL CONTINUE TO MONITOR THIS INSTRUMENT FOR COMPLAINTS FROM THE FIELD.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED COMMUNICATION ON (B)(6) 2021 FOR A SYSTEM SCREWDRIVER THAT WAS REPORTED TO NOT FUNCTION AS INTENDED DUE TO HAVING A WORN SQUARE THREAD DETAIL AND WAS REQUESTED TO BE REPLACED. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATE AVAILABLE INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH ARRIVED AT THE COMPANY FOR COMPLAINT ASSESSMENT ON 6/04/2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945947 FORTEX PEDICLE SCREW SYSTEM PEDICLE SCREW SPINAL SYSTEM MNH XTANT MEDICAL X022-0240 025859 M697X02202401

    Patients

    Seq Age Sex Outcome Treatment
    1