BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE SCREW, 1.4X9MM, CORTICAL, TI

    MDR report key: 15833687 · Received November 21, 2022

    Report

    Report Number
    1220246-2022-05770
    Event Type
    Malfunction
    Date Received
    November 21, 2022
    Date of Event
    October 31, 2022
    Report Date
    November 21, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867303867
    PMA / PMN Number
    K191326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    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. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A AR-18714-08, AR-18714-07, AND A AR-18714-09 SCREW BROKE. THIS OCCURRED DURING A PHALANX FRACTURE ON (B)(6) 2022 WHEN INSERTING THE AR-18714-08 SCREW IT BROKE ABOUT 3/4 OF THE WAY, THE SURGEON THEN ATTEMPTED TO INSERT A AR-18714-09 SCREW TO SECURE THE PLATE TO THE BONE, UPON INSERTION THE SCREW BROKE. THEN A AR-18714-07 SCREW WAS USED TO SECURE THE PLATE AS IT WAS ALREADY DOWN, WHEN ATTEMPTING TO SECURE THE PLATE IT BROKE. ALL BROKEN FRAGMENTS REMAIN IN THE PATIENT. THE PATIENT HAD VERY GOOD BONE QUALITY AND THE SOCKETS WERE PREPPED FOR INSERTION WITH A AR-18700-06 DRILL BIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385226 LOW PROFILE SCREW, 1.4X9MM, CORTICAL, TI PLATE, FIXATION, BONE HRS ARTHREX, INC. LOW PROFILE SCREW, 1.4X9MM, CORTICAL, TI 00888867303867

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown