BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXLE INTERSPINOUS FUSION SYSTEM

    MDR report key: 10289073 · Received July 17, 2020

    Report

    Report Number
    3005031160-2020-00017
    Event Type
    Malfunction
    Date Received
    July 17, 2020
    Date of Event
    June 24, 2020
    Report Date
    July 17, 2020
    Manufacturer
    XTANT MEDICAL
    Product Code
    HTC
    UDI-DI
    M697X06015201
    PMA / PMN Number
    K130438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY RECEIVED NOTIFICATION ON (B)(6) 2020 THAT A SURGICAL INSTRUMENT HAD A MALFUNCTION DURING A SURGICAL PROCEDURE. IT WAS REPORTED THAT THE DISTAL END OF A SYSTEM INSERTER/COMPRESSOR FRACTURED WHEN BEING USED TO COMPRESS IMPLANT PLATES. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THERE WAS AN ALTERNATE INSTRUMENT AVAILABLE, WHICH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A VISUAL ASSESSMENT OF THE RETURNED INSERTER/COMPRESSOR SHOWED AN INSTRUMENT WITH REPEATED USE, AS IDENTIFIED BY SURFACE SCRATCHES, WORN LASER MARKINGS, AND MINOR SURFACE STAINING. THE HANDLE A TIP WAS BROKEN FROM THE BODY OF THE INSTRUMENT. THE METAL CYLINDER AT THE PROXIMAL END OF THE HANDLE A TIP WAS SHEARED OFF, LEAVING A PORTION OF THE FRACTURED CYLINDER WITHIN THE HANDLE A MAIN BODY. A FUNCTIONALITY ASSESSMENT COULD NOT BE PERFORMED DUE TO THE BROKEN CONDITION OF THE INSTRUMENT. A DHR REVIEW WAS PERFORMED FOR THE COMPLAINT LOT AND THE DEVICES MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. THIS LOT HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 12/19/18. IT MAY BE POSSIBLE THAT APPLICATION OF EXCESSIVE COMPRESSION FORCE MAY HAVE CONTRIBUTED TO THE HANDLE A TIP FRACTURING FROM THE INSTRUMENT. THE HANDLE A TIP IS SECURED INTO THE BODY OF THE INSTRUMENT WITH A CYLINDER THAT HAS MINOR MOVEMENT TO ALLOW FOR IMPLANT ENGAGEMENT. IT MAY BE POSSIBLE THAT OVER COMPRESSING THE INSTRUMENT MAY CONCENTRATE APPLIED FORCE TO THE HANDLE A TIP, RESULTING IN AN INSTRUMENT MALFUNCTION.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED NOTIFICATION ON (B)(6) 2020 THAT A SURGICAL INSTRUMENT HAD A MALFUNCTION DURING A SURGICAL PROCEDURE. IT WAS REPORTED THAT THE DISTAL END OF A SYSTEM INSERTER/COMPRESSOR FRACTURED WHEN BEING USED TO COMPRESS IMPLANT PLATES. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THERE WAS AN ALTERNATE INSTRUMENT AVAILABLE, WHICH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755024 AXLE INTERSPINOUS FUSION SYSTEM PLIERS ALL-IN-ONE, INSERTER/COMPRESSOR, ASSEMBLY HTC XTANT MEDICAL X060-1520 10675 M697X06015201

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other