BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IB KIT, PEEK, NON-COLLAGEN COATED

    MDR report key: 19751525 · Received July 16, 2024

    Report

    Report Number
    1220246-2024-06776
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    June 25, 2024
    Report Date
    October 3, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED CANNULATED 3.4MM DRILL WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED THAT THE TIP OF THE DEVICE WAS BROKEN AND A FRAGMENT WAS MISSING. THE MISSING FRAGMENT WAS NOT RETURNED FOR EVALUATION. DIMENSIONAL TESTING WAS PERFORMED USING A CALIPER ID: 1003729. THE LENGTH OF THE DEVICE WAS MEASURED AND FOUND TO BE 4.367, INDICATING THAT THE MISSING FRAGMENT IS AROUND .243, AS THE LENGTH DIMENSION SPECIFIED IN DRAWING C16909 REV 6 IS 4.500. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO MISALIGNED INSERTION AND/OR PRYING/LEVERAGING THE DEVICE DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ATFL/CFL INTERNAL BRACE SURGERY THE SURGEON USED THE CANNULATED 3.4MM DRILL WITH THE KWIRE. SURGEON VOICED THAT THE K-WIRE WAS SLIGHTLY BENT DUE TO PLACEMENT AND HE IS NOT CONCERNED. PART OF THE DRILL BIT BROKE OFF INSIDE THE PATIENT. THE SHRAPNEL OF THE CANNULATED DRILL HAS BEEN REMOVED AFTER IT WAS NOTICED ON THE X-RAY. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE, SINCE THE FAILURE WAS NOTICED AFTER THE DRILLING WAS COMPLETED. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694314 IB KIT, PEEK, NON-COLLAGEN COATED BIO SOFT TISSUE FIXATN FASTNR MAI ARTHREX, INC. IB KIT, PEEK, NON-COLLAGEN COATED 15210346

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown