BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEFTY TIGHT LAG SCREW, Ø10.5MM X 90MM

    MDR report key: 15200736 · Received August 10, 2022

    Report

    Report Number
    1220246-2022-05354
    Event Type
    Malfunction
    Date Received
    August 10, 2022
    Date of Event
    November 22, 2021
    Report Date
    August 10, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665036534
    PMA / PMN Number
    K202099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE SECOND THREAD WAS BROKEN OFF. THE BROKEN PIECE WAS NOT RETURNED FOR EVALUATION. THE CAUSE OF THIS REMAINS UNDETERMINED.

    Description of Event or Problem · 0

    ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 1192-090 LEFTY TIGHT LAG SCREW BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021. WHEN THE SURGEON ATTEMPTED TO ADVANCE THE SCREW, IT BROKE INSIDE THE PATIENT. THE SCREW WAS RETRIEVED AND WAS REPLACED WITH AN 1099-090 GALILEO LAG SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1785527 LEFTY TIGHT LAG SCREW, Ø10.5MM X 90MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ARTHREX, INC. LEFTY TIGHT LAG SCREW, Ø10.5MM X 90MM 202340 00848665036534

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown