BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFUSION SCREW, 20MM

    MDR report key: 9585892 · Received January 14, 2020

    Report

    Report Number
    1220246-2020-01575
    Event Type
    Injury
    Date Received
    January 14, 2020
    Date of Event
    October 11, 2019
    Report Date
    May 19, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867187825
    PMA / PMN Number
    K151078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED, THE SCREW WAS FOUND TO BE BROKEN IN TWO PIECES. LIKELY CAUSES INCLUDE IMPROPER BONE PREP, PRYING/LEVERAGING THE DEVICE DURING INSERTION, CONTINUALLY APPLYING TORQUE WHEN THE DEVICE IS NOT ADVANCING.

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PIP JOINT FIXATION PROCEDURE; AS THE SURGEON WAS COMPLETING THE FDH/FHL EXTENSION AND FIXATION OF 2ND TO 5TH TOE, THE RETROFUSION SCREW, (B)(4), BROKE AT THE MIDDLE OF THE SHAFT; LEAVING BROKEN PIECES INSIDE THE PROXIMAL PHALANX. THE BROKEN PIECES WERE COMPLETELY REMOVED DURING THE SURGERY USING A SCREW EXTRACTION DEVICE MADE BY ANOTHER MANUFACTURER. THE BONE HOLE WAS SUPPLEMENTED WITH BONE FROM THE OTHER TOES, AND THE 3RD TOE ON THE RIGHT FOOT WAS FIXED WITH A C WIRE. THE SURGERY WAS COMPLETED, AND NO ABNORMALITIES WERE FOUND IN POST-OPERATIVE X-RAYS. THE PROCEDURES FOR THE 4TH AND 5TH TOES ON THE RIGHT FOOT AND THE 3RD TO 5TH TOE OF THE LEFT FOOT WERE CHANGED TO A PROCEDURE THAT UTILIZES C WIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52525 RETROFUSION SCREW, 20MM SCREW, FIXATION, BONE HWC ARTHREX, INC. RETROFUSION SCREW, 20MM 10305533 00888867187825

    Patients

    Seq Age Sex Outcome Treatment
    1 Other