BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIS 3.9MM BC ACHILLES SPDBRG W/ KL DX CC

    MDR report key: 19905044 · Received August 5, 2024

    Report

    Report Number
    1220246-2024-07017
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    May 30, 2024
    Report Date
    September 27, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867389533
    PMA / PMN Number
    K201749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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 DRILL BIT LOT NUMBER: 032321 THAT IS PART OF AN AR-9928BCK-MIS MINI-OPEN FIBERTAK® ACHILLES SPEEDBRIDGE¿ REPAIR IMPLANT SYSTEM LOT NUMBER: 15222869 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED THAT THE TIP OF THE DEVICE WAS BROKEN AND A FRAGMENT WAS MISSING. DIMENSIONAL TESTING WAS PERFORMED USING A CALIPER ID: 1003729. THE LENGTH OF THE DEVICE WAS MEASURED AND FOUND TO BE 3.330, INDICATING THAT THE MISSING FRAGMENT IS AROUND .050, AS THE LENGTH DIMENSION SPECIFIED IN DRAWING C20663 REV 8 IS 3.380. 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

    ON 7/15/2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT DURING DRILLING FOR THE PLACEMENT OF A DISTAL INTERFERENCE SCREW, A SMALL FRAGMENT OF THE DRILL BIT WAS NOTICED IN THE CALCANEAL WOUND. THE FRAGMENT WAS VERIFIED BY FLUOROSCOPY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6)2024. ADDITIONAL INFORMATION RECEIVED ON 7/18/2024: THE BROKEN DRILL WAS PART OF AN AR-9928BCK-MIS FIBERTAK ACHILLES SPEEDBRIDGE IMPLANT SYSTEM. THE BROKEN FRAGMENTS WERE NOT REMOVED, AS A RETRIEVAL ATTEMPT WOULD HAVE BEEN MORE PROBLEMATIC. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2294852 MIS 3.9MM BC ACHILLES SPDBRG W/ KL DX CC BIO SOFT TISSUE FIXATN FASTNR HWC ARTHREX, INC. MIS 3.9MM BC ACHILLES SPDBRG W/ KL DX CC 15222869 00888867389533

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown