BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTEX SPINAL FIXATION SYSTEM

    MDR report key: 10610679 · Received September 30, 2020

    Report

    Report Number
    3005031160-2020-00024
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    September 9, 2020
    Report Date
    September 30, 2020
    Manufacturer
    XTANT MEDICAL
    Product Code
    HXX
    UDI-DI
    M697X06704401
    PMA / PMN Number
    K160428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT PROVIDED A PHOTO OF THE REPORTED INSTRUMENT MALFUNCTIONS, WHICH SHOWED SYSTEM SCREWS STUCK TO THE DISTAL THREADS OF TWO SYSTEM SCREWDRIVERS. THE THREAD DETAIL OF THE SYSTEM SCREWDRIVERS WERE FRACTURED AND STUCK IN THE CUP OF THE SYSTEM SCREWS. A VISUAL ASSESSMENT OF THE RETURNED SYSTEM SCREWDRIVERS SHOWED INSTRUMENTS WITH REPEATED USE, AS IDENTIFIED BY SURFACE SCRATCHES, HANDLE INTERFACE WEAR MARKS, AND WORN LASER MARKINGS. A PHYSICAL ASSESSMENT COULD NOT BE PERFORMED DUE TO THE DAMAGED CONDITION OF THE RETURNED SYSTEM SCREWDRIVERS, WHICH WOULD NOT FUNCTION AS INTENDED AND WERE REMOVED FROM DISTRIBUTABLE INVENTORY. A DHR REVIEW WAS PERFORMED FOR THE RETURNED COMPLAINT DEVICE LOT AND THERE WERE NO MANUFACTURING ANOMALIES IDENTIFIED. THE DEVICE MET ALL REQUIRED SPECIFICATION PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. THIS LOT HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 8/26/2016. IT MAY BE POSSIBLE TO FRACTURE THE THREAD DETAIL OF A SYSTEM SCREWDRIVER IF THE RATCHETING SCREWDRIVER HANDLE ATTACHED TO THE SCREWDRIVER WAS NOT IN THE CORRECT POSITION FOR SCREW PLACEMENT AND SCREW DISENGAGEMENT. THE SYSTEM SURGICAL TECHNIQUE GUIDE PROVIDES GUIDANCE ON APPROPRIATE SCREWDRIVER AND SCREW ENGAGEMENT AND DISENGAGEMENT. STEP FIVE: SCREWDRIVER/SCREW ASSEMBLY INCLUDES THE FOLLOWING CAUTIONARY STATEMENTS TO REDUCE THE POSSIBILITY OF AN INSTRUMENT MALFUNCTION. CAUTIONARY STATEMENTS FROM THE SURGICAL TECHNIQUE GUIDE: WARNING - 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. NOTE: 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. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE RELIABLY DETERMINED. THE COMPLAINT INVESTIGATION SUGGESTS THE POSSIBILITY THAT THE RATCHETING SCREWDRIVER HANDLE ATTACHED TO THE SYSTEM SCREWDRIVER WAS NOT IN THE CORRECT RATCHETING POSITION FOR SCREW ENGAGEMENT AND DISENGAGEMENT.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED NOTIFICATION ON 9/09/2020 FROM A DISTRIBUTOR REQUESTING REPLACEMENT OF TWO SYSTEM SCREWDRIVERS. IT WAS REPORTED THAT THE THREAD DETAIL AT THE DISTAL TIP OF TWO SYSTEM SCREWDRIVERS WERE DEFECTIVE. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THERE WAS APPROXIMATELY A 10-MINUTE DELAY WHILE ALTERNATE INSTRUMENTS WERE GATHERED, WHICH WERE 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 9/24/2020. REPORT #3005031160-2020-0021 IS ASSOCIATED WITH THIS SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075275 CERTEX SPINAL FIXATION SYSTEM CERTEX SCREWDRIVER ASSEMBLY HXX XTANT MEDICAL X067-0440 055732 M697X06704401

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other