BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTEX PEDICLE SCREW SYSTEM

    MDR report key: 12984798 · Received December 13, 2021

    Report

    Report Number
    3005031160-2021-00026
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    Date of Event
    November 18, 2021
    Report Date
    December 13, 2021
    Manufacturer
    XTANT MEDICAL
    Product Code
    MNI
    UDI-DI
    M697X02202401
    PMA / PMN Number
    K152132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL ASSESSMENT OF THE RETURNED COMPLAINT SCREWDRIVER SHOWED AN INSTRUMENT WITH REPEATED USE, AS IDENTIFIED BY SURFACE SCRATCHES AND HANDLE ENGAGEMENT MARKS. APPROXIMATELY HALF OF THE SQUARE THREAD DETAIL WAS FRACTURED FROM THE SLEEVE OF THE INSTRUMENT. THE HEX TIP WAS WORN AND ROUNDED WITH THE TIN COATING WEARING FROM THE DISTAL END OF THE INSTRUMENT. A FUNCTIONALITY ASSESSMENT WAS NOT PERFORMED DUE TO THE DAMAGED CONDITION OF THE RETURNED INSTRUMENT, WHICH WAS REMOVED FROM DISTRIBUTABLE INVENTORY. A DHR REVIEW WAS PERFORMED FOR THE SCREWDRIVER COMPLAINT LOT AND THERE WERE NO 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 4/15/2016. IT MAY BE POSSIBLE FOR THE SQUARE THREAD DETAIL OF A SCREWDRIVER TO FRACTURE IF EXCESSIVE ROTATIONAL FORCE WAS APPLIED TO THE SLEEVE OF THE SCREWDRIVER OR IF THE ATTACHED HANDLE WAS NOT IN THE NEUTRAL POSITION WHEN ROTATED. THE SLEEVE OF THE SCREWDRIVER IS TIGHTENED INTO THE CUP OF THE SYSTEM SCREW TO SECURE IT TO THE DRIVER AND PREVENT TOGGLE. IF THE SLEEVE WAS ROTATED BEYOND WHAT IS REQUIRED TO SECURE THE SCREW, IT MAY FRACTURE THE SQUARE THREAD DETAIL AS OBSERVED. THERE IS A CAUTIONARY NOTE INCLUDED IN THE ASSOCIATED 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 INCLUDING CAUSING THEM TO BREAK OFF COMPLETELY." THERE HAS BEEN ONE OTHER COMPLAINT OF SIMILAR NATURE IN THE PAST 12 MONTHS. THE MANUFACTURER WILL CONTINUE TO MONITOR THIS INSTRUMENT FOR COMPLAINTS FROM THE FIELD.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED NOTIFICATION OF A SYSTEM SCREWDRIVER MALFUNCTION ON 11/18/2021. IT WAS REPORTED THAT THE DISTAL THREADS OF A SYSTEM SCREWDRIVER FRACTURED WHILE BEING USED IN A SURGICAL PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATE DRIVER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE COMPLAINT SCREWDRIVER WAS RECEIVED ON 11/24/2021 AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1884889 FORTEX PEDICLE SCREW SYSTEM PEDICLE SCREW SPINAL SYSTEM MNI XTANT MEDICAL X022-0240 6679-01 M697X02202401

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other