BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20017672 · Received August 21, 2024

    Report

    Report Number
    1220246-2024-07194
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    July 17, 2024
    Report Date
    July 3, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665036534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    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 THE COMPLAINT ALLEGATION IS CONFIRMED BASED ON THE CUSTOMER-PROVIDED PICTURES. VISUAL EVALUATION OF THE CUSTOMER-PROVIDED PICTURES NOTED A TELESCOPING LAG SCREW UNTHREADED INSIDE THE PATIENT. REFER TO ATTACHMENTS. BASED ON THE INFORMATION PROVIDED, 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 OVER-TORQUING THE SCREW WHEN INSERTING INTO THE PLATE AND/OR HARD BONE.

    Description of Event or Problem · 0

    ON 07/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 1192-090 LEFTY TELESCOPING LAG SCREW UNTHREADED INSIDE THE PATIENT. THE THREADS BROKE, AND THE SCREW WAS LEFT IMPLANTED. THIS WAS DISCOVERED DURING A HIP NAIL PROCEDURE ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300036 LEFTY TIGHT LAG SCREW, Ø10.5MM X 90MM INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. LEFTY TIGHT LAG SCREW, Ø10.5MM X 90MM 212114 00848665036534

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown