BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE SCREW, 1.4X12MM, CORTICAL,TI

    MDR report key: 17573533 · Received August 18, 2023

    Report

    Report Number
    1220246-2023-07552
    Event Type
    Malfunction
    Date Received
    August 18, 2023
    Date of Event
    July 19, 2023
    Report Date
    December 27, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867303829
    PMA / PMN Number
    K191326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO EXCESSIVE USER-APPLIED MECHANICAL FORCES.

    Description of Event or Problem · 0

    ON 07/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-18714-12 SCREW AND AN AR-18714V-13 SCREW BROKE ABOUT HALFWAY DOWN THE THREADS. THIS WAS DISCOVERED DURING A CASE DEVIATION LONGER THAN 15 MINUTES, SCREWS WERE UNABLE TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2331363 LOW PROFILE SCREW, 1.4X12MM, CORTICAL,TI BONE FIXATION PLATE HRS ARTHREX, INC. LOW PROFILE SCREW, 1.4X12MM, CORTICAL,TI UNK 00888867303829

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown