BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21293645 · Received February 3, 2025

    Report

    Report Number
    1220246-2025-00135
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    January 7, 2025
    Report Date
    April 9, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665036534
    PMA / PMN Number
    K202099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED 1192-090 SERIAL/BATCH NUMBER (B)(6), WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION NOTED SIGNS OF DAMAGE ALONG THE DEVICE'S THREADS. ADDITIONALLY, THE COMPRESSION SLEEVE WAS RETURNED INTACT. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE NICKS NOTICED ALONG THE RETURNED DEVICE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR DUE TO MISALIGNED INSERTION AND/OR IMPROPER BONE PREPARATION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON 01/07/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 1192-090 LEFT LAG SCREW WOULD NOT ADVANCE THROUGH THE NAIL AND WAS SPINNING INSTEAD. THE SURGEON TRIED MULTIPLE TIMES TO REDRILL AND REINSERT THE SCREW WITHOUT SUCCESS AND DEEMED IT NOT FUNCTIONAL. NO PIECES BROKE OFF INSIDE THE PATIENT. THE SURGEON PROCEEDED TO IMPLANT A STANDARD RIGHT-THREADED LAG SCREW WHICH WAS IMPLANTED SUCCESSFULLY. THIS WAS DISCOVERED DURING A HIP FRACTURE PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 1/20/2025: THE CASE WAS COMPLETED USING A 1099-090 TELESCOPING LAG SCREW. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076241 LEFTY TIGHT LAG SCREW, Ø10.5MM X 90MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ARTHREX, INC. LEFTY TIGHT LAG SCREW, Ø10.5MM X 90MM 212113 00848665036534

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown