BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR FT SCRW,4.0 STD,34MM LGTH

    MDR report key: 8739448 · Received June 27, 2019

    Report

    Report Number
    1220246-2019-01178
    Event Type
    Injury
    Date Received
    June 27, 2019
    Date of Event
    June 12, 2019
    Report Date
    June 27, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867127722
    PMA / PMN Number
    K150456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    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 PROCEDURE, THE SURGEON WAS ATTEMPTING TO REMOVE A 4.0 HEADLESS SCREW FROM THE PROXIMAL TIBIA WITH A T10 HEXALOBE DRIVER, AR-8737-38, AND THE TIP BROKE OFF INTO THE HEAD OF THE SCREW. THE TIP WAS ABLE TO BE REMOVED FROM THE HEAD WITH NO ISSUE. THE SURGEON THEN USED A CANNULATED T10 HEXALOBE DRIVER, AR-8737-26, TO FINISH THE REMOVAL OF THE TIP OF THE DRIVER WHICH BECAME TWISTED. THE SCREW WAS ABLE TO BE REMOVED WITH THE SECOND DRIVER WITH NO ISSUE TO THE PATIENT. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED (B)(6) 2019: THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2019 WHERE A 4.0 HEADLESS SCREW, AR-8740-34H, WAS IMPLANTED. SHORTLY AFTER, THE PATIENT BEGAN EXPERIENCING PAIN AND HAD TO HAVE A SECOND SURGERY TO HAVE THE SCREW REMOVED ON (B)(6) 2019. PAIN IS THE ONLY SYMPTOM THE PATIENT WAS EXPERIENCING AND IT WAS THE ONLY DEVICE REMOVED DURING THE REVISION PROCEDURE. NO HARDWARE WAS PUT IN ITS PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533314 COMPR FT SCRW,4.0 STD,34MM LGTH PLATE, FIXATION, BONE HRS ARTHREX, INC. COMPR FT SCRW,4.0 STD,34MM LGTH 00888867127722

    Patients

    Seq Age Sex Outcome Treatment
    1 Other