BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARANAX CERVICAL PLATING SYSTEM

    MDR report key: 11966979 · Received June 9, 2021

    Report

    Report Number
    3005031160-2021-00011
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 12, 2021
    Report Date
    June 9, 2021
    Manufacturer
    XTANT MEDICAL
    Product Code
    KWQ
    UDI-DI
    M697T08612001
    PMA / PMN Number
    K150834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL ASSESSMENT OF THE RETURNED SYSTEM SCREWDRIVER SHOWED AN INSTRUMENT WITH REPEATED USE, AS IDENTIFIED BY WORN LASER MARKINGS AND SURFACE SCRATCHES. THE HEX TIP WAS FRACTURED AS REPORTED, AND THE SPRING TIP WAS ALSO FRACTURED. A FUNCTIONALITY ASSESSMENT WAS NOT PERFORMED DUE TO THE DAMAGED CONDITION OF THE RETURNED SYSTEM SCREWDRIVER, WHICH WAS REMOVED FROM DISTRIBUTABLE INVENTORY. A DHR REVIEW WAS PERFORMED FOR THE COMPLAINT INSTRUMENT LOT AND THERE WERE NO MANUFACTURING ANOMALIES IDENTIFIED. THE DEVICE MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. THIS LOT HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE (B)(6) 2015. IT MAY BE POSSIBLE FOR THE DISTAL TIP OF A SYSTEM SCREWDRIVER TO FRACTURE DURING SCREW PLACEMENT IF EXCESSIVE ROTATIONAL FORCE WAS APPLIED TO THE DRIVER. THE RESILIENT LOCKING ARM OF THE IMPLANT PLATE PROVIDES TACTILE AND AUDIBLE VERIFICATION WHEN THE IMPLANT SCREW HAS BEEN APPROPRIATELY PLACED AND THE DRIVER SUFFICIENTLY ROTATED. IT MAY ALSO BE POSSIBLE FOR THE DRIVER DISTAL TIP TO FRACTURE DURING SCREW PLACEMENT IF THE SYSTEM SCREWDRIVER WAS ROTATED AT AN ANGLE. IF THE SYSTEM SCREWDRIVER WAS ROTATED WHILE SEATED IN A SYSTEM SCREW AT AN ANGLE, IT MAY BE POSSIBLE FOR THE APPLIED FORCE TO BE CONCENTRATED ON THE PARTIALLY ENGAGED PORTION OF THE INSTRUMENT AND SCREW, WHICH COULD CONTRIBUTE TO AN INSTRUMENT MALFUNCTION. THERE HAS BEEN ONE OTHER COMPLAINT 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 NOTIFICATION ON 5/14/2021 OF A SYSTEM SCREWDRIVER WITH A DISTAL TIP THAT MALFUNCTIONED DURING AN ACDF PROCEDURE ON (B)(6) 2021. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. AN AVAILABLE ALTERNATE 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 5/19/2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862894 ARANAX CERVICAL PLATING SYSTEM CERVICAL PLATING SYSTEM KWQ XTANT MEDICAL T086-1200 EM15J052 M697T08612001

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR