BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTEX SPINAL IMPLANT SYSTEM

    MDR report key: 8661033 · Received May 31, 2019

    Report

    Report Number
    3005031160-2019-00028
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    Date of Event
    April 12, 2019
    Report Date
    May 31, 2019
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    HXX
    UDI-DI
    M697X06704401
    PMA / PMN Number
    K122163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT REPORTED THAT A TECHNICIAN PLACED A 3.5X10MM SCREW ON THE DISTAL END OF EACH SCREWDRIVER. THE SURGEON REQUESTED A DIFFERENT SIZE SCREW. THE SCREW WAS UNABLE TO BE REMOVED FROM ONE OF THE SCREWDRIVERS. THE TECHNICIAN SET ASIDE THE SCREWDRIVER AND USED THE OTHER SCREWDRIVER THAT WAS AVAILABLE. WHEN THE TECHNICIAN WAS ABLE TO INSPECT THE DEFECTIVE SCREWDRIVER, IT WAS NOTICED THAT THE THREAD THAT ENTERS THE SCREW WAS BROKEN. THERE WERE NO REPORTED PATIENT COMPLICATIONS. A VISUAL ASSESSMENT OF THE DRIVER ASSEMBLY SHOWED AN INSTRUMENT WITH REPEATED USE. THE THREAD DETAIL ON THE DISTAL END OF THE SCREWDRIVER WAS BROKEN. A FUNCTIONALITY ASSESSMENT COULD NOT BE PERFORMED DUE TO THE BROKEN THREAD DETAIL. A DHR REVIEW WAS PERFORMED FOR LOT# 054355 AND THERE WERE NO MANUFACTURING ANOMALIES IDENTIFIED. THE INSTRUMENT MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING INITIALLY RELEASED TO DISTRIBUTABLE INVENTORY. THE SURGICAL TECHNIQUE GUIDE (STEP 5: SCREWDRIVER/SCREW ASSEMBLY) OUTLINES THE STEPS THAT MUST BE PERFORMED TO CORRECTLY LOAD A PEDICLE SCREW. INCLUDING A WARNING "IF THE RATCHETING SCREWDRIVER HANDLE (ATTACHED TO THE PROXIMAL END OF THE PEDICLE SCREWDRIVER) 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 ALSO A NOTE FOR THIS STEP WHICH 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." IT IS UNCLEAR IF ALL STEPS IN THE SURGICAL TECHNIQUE GUIDE WERE FOLLOWED WHEN LOADING THE AND DISENGAGING THE PEDICLE SCREW.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT A TECHNICIAN PLACED A 3.5X10MM SCREW ON THE DISTAL END OF EACH SCREWDRIVER. THE SURGEON REQUESTED A DIFFERENT SIZE SCREW. THE SCREW WAS UNABLE TO BE REMOVED FROM ONE OF THE SCREWDRIVERS. THE TECHNICIAN SET ASIDE THE SCREWDRIVER AND USED THE OTHER SCREWDRIVER THAT WAS AVAILABLE. WHEN THE TECHNICIAN WAS ABLE TO INSPECT THE DEFECTIVE SCREWDRIVER, IT WAS NOTICED THAT THE THREAD THAT ENTERS THE SCREW WAS BROKEN. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451873 CERTEX SPINAL IMPLANT SYSTEM SPINAL IMPLANTS HXX X-SPINE SYSTEMS, INC. X067-0440 054355 M697X06704401

    Patients

    Seq Age Sex Outcome Treatment
    1 Other