BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEFTY TIGHTY LAG SCREW, Ø10.5MM X 110MM

    MDR report key: 18768565 · Received February 23, 2024

    Report

    Report Number
    1220246-2024-01088
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    January 28, 2024
    Report Date
    May 29, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665036572
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. 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 USER ERROR OF THE DEVICE DUE TO APPLYING EXCESSIVE MECHANICAL FORCES UPON INSERTION AND/OR MISALIGNED THE INSERTION. THE COMPLAINT ALLEGATION WAS CONFIRMED BASED ON THE CUSTOMER'S ATTACHED PICTURE WHICH DISPLAYS THE 1192-110 WITH THE THREADS DAMAGED AND SCRATCHES LINES ON THE SHAFT.

    Description of Event or Problem · 0

    ON 1/30/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 1192-110 TELESCOPING LAG SCREW LEFT DETHREADED DURING INSERTION. THE CASE WAS COMPLETED USING A 10.5MM X 115MM SCREW. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124689 LEFTY TIGHTY LAG SCREW, Ø10.5MM X 110MM INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. LEFTY TIGHTY LAG SCREW, Ø10.5MM X 110MM 212129 00848665036572

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown