BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTEX SPINAL FIXATION SYSTEM

    MDR report key: 12925527 · Received December 3, 2021

    Report

    Report Number
    3005031160-2021-00025
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    October 29, 2021
    Report Date
    December 3, 2021
    Manufacturer
    XTANT MEDICAL
    Product Code
    KWP
    UDI-DI
    M697X06704401
    PMA / PMN Number
    K160428
    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 SYSTEM SCREWDRIVER SHOWED AN INSTRUMENT WITH REPEATED USE, AS IDENTIFIED BY SURFACE SCRATCHES AND STAINING. THE TIN COATING AT THE DISTAL END OF THE RETURNED COMPLAINT INSTRUMENT WAS IDENTIFIED AS WORN. THE SQUARE THREAD DETAIL ON THE RETURNED SYSTEM SCREWDRIVER WAS FRACTURED FROM THE SCREWDRIVER SLEEVE AND THE DISTAL HEX TIP OF THE SCREWDRIVER WAS SLIGHTLY ROUNDED. A FUNCTIONALITY ASSESSMENT WAS NOT PERFORMED DUE TO THE DAMAGED CONDITION OF THE SYSTEM SCREWDRIVER, 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 8/26/2016. IT MAY BE POSSIBLE FOR THE SQUARE THREAD DETAIL OF A SYSTEM 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 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 HAVE NOT BEEN ANY OTHER COMPLAINTS OF SIMILAR NATURE FOR THIS DEVICE IN THE PAST 12 MONTHS. THE MANUFACTURER WILL CONTINUE TO MONITOR THIS DEVICE FOR COMPLAINTS FROM THE FIELD.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED NOTIFICATION OF A SYSTEM SCREWDRIVER MALFUNCTION ON 11/04/2021. IT WAS REPORTED THAT THE DISTAL SQUARE THREAD DETAIL OF A SYSTEM SCREWDRIVER FRACTURED WHILE TIGHTENING A SYSTEM SCREW. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATE AVAILABLE INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE SURGICAL PROCEDURE. THE COMPLAINT SCREWDRIVER WAS RECEIVED ON 12/01/2021 AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT. THIS REPORT IS ASSOCIATED WITH MDR 3005031160-2021-00024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1821481 CERTEX SPINAL FIXATION SYSTEM SPINAL IMPLANTS KWP XTANT MEDICAL X067-0440 055732 M697X06704401

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other