BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRIX-C CERVICAL INTEGRATED FUSION SYSTEM

    MDR report key: 18768792 · Received February 23, 2024

    Report

    Report Number
    3005031160-2024-00002
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    January 17, 2024
    Report Date
    February 23, 2024
    Manufacturer
    XTANT MEDICAL HOLDINGS, INC.
    Product Code
    HWB
    UDI-DI
    M697T06602131
    PMA / PMN Number
    K162944
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL ASSESSMENT OF THE RETURNED SYSTEM SCREW REMOVAL INSTRUMENT SHOWED AN INSTRUMENT WITH REPEATED USE, AS IDENTIFIED BY WORN LASER MARKINGS AND SURFACE SCRATCHES. THE INNER SHAFT OF THE SYSTEM SCREW REMOVAL INSTRUMENT WAS FRACTURED AS REPORTED AND THE DISTAL TIP WAS DAMAGED AND BENT. THE INNER SHAFT WAS DAMAGED AROUND THE AREA WHERE THE FRACTURE OCCURRED. THERE WERE ROTATIONAL SCRATCHES PRESENT ON THE DISTAL PORTION OF THE BENT SHAFT AND WAS TWISTED IN A MANNER THAT REFLECTED BEING ROTATED COUNTERCLOCKWISE WHEN DAMAGED. A FUNCTIONALITY ASSESSMENT WAS NOT PERFORMED DUE TO THE DAMAGED CONDITION OF THE RETURNED SYSTEM SCREW REMOVAL INSTRUMENT, WHICH WAS REMOVED FROM DISTRIBUTABLE INVENTORY. A DHR REVIEW WAS PERFORMED FOR COMPLAINT LOT# 2408-01 AND THERE WERE NO MANUFACTURING DEFICIENCIES IDENTIFIED. THE DEVICE LOT MET ALL REQUIRED SPECIFICATIONS PRIOR TO BE RELEASED TO DISTRIBUTABLE INVENTORY. THIS LOT HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 2/06/2014. IT MAY BE POSSIBLE FOR THE INNER SHAFT OF A SYSTEM SCREW REMOVAL INSTRUMENT TO FRACTURE WHILE REMOVING AN IMPLANT SCREW IF EXCESSIVE ROTATIONAL FORCE WAS APPLIED. IT MAY BE POSSIBLE TO APPLY EXCESSIVE ROTATIONAL FORCE TO THE SYSTEM SCREW REMOVAL INSTRUMENT IF THE IMPLANT SCREW BEING REMOVED DID NOT HAVE CLEARANCE TO BE REMOVED FROM THE SPACER. IF THE SLEEVE OF THE SYSTEM SCREW REMOVAL INSTRUMENT IS NOT APPROPRIATELY ROTATED TO ALLOW THE IMPLANT SCREW TO PASS BY THE LOCKING ARM OF THE SPACER, THE ROTATIONAL FORCE APPLIED MAY BE CONCENTRATED TO THE INNER SHAFT AND RESULT IN THE MALFUNCTION OBSERVED. THERE HAVE NOT BEEN ANY OTHER COMPLAINTS OF SIMILAR NATURE FOR THE IRIX-C SCREW REMOVAL INSTRUMENT IN THE PAST 12 MONTHS. THE MANUFACTURER WILL CONTINUE TO MONITOR THE FIELD FOR COMPLAINTS WITH THE SYSTEM SCREW REMOVAL INSTRUMENT.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 1/24/2024. IT WAS REPORTED THAT THE INTERNAL SHAFT OF A SYSTEM SCREW REMOVAL TOOL MALFUNCTIONED DURING A SURGICAL PROCEDURE. THE COMPLAINT SOURCE STATED, "WHEN THE SURGEON WAS TRYING TO BACK OUT A SCREW THAT WAS TOO LONG, THE TOP HALF OF THE INNER SHAFT SNAPPED OFF." THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLIANT. AN RMA# WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH ARRIVED AT THE MANUFACTURER FOR ASSESSMENT ON 1/25/2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124701 IRIX-C CERVICAL INTEGRATED FUSION SYSTEM INTERVERTEBRAL BODY FUSION DEVICE HWB XTANT MEDICAL HOLDINGS, INC. T066-0213 2408-01 M697T06602131

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other