BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEFTY TIGHTY LAG SCREW, Ø10.5MMX100MM

    MDR report key: 20463005 · Received October 16, 2024

    Report

    Report Number
    1220246-2024-08166
    Event Type
    Injury
    Date Received
    October 16, 2024
    Date of Event
    August 27, 2024
    Report Date
    June 10, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665036558
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 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 MISALIGNED INSERTION.

    Description of Event or Problem · 0

    ON 9/10/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A 0857-100 CAPTURING ROD AND 1192-100 LEFTY TIGHTY LAG SCREW GOT STUCK TOGETHER AND COULD NOT BE TAKEN APART. THIS WAS DISCOVERED DURING A TROCH NAIL PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED USING A NEW 0857-100 CAPTURING ROD AND 1192-100 LEFTY TIGHTLY LAG SCREW. ADDITIONAL INFORMATION RECEIVED ON 9/27/2024: IT WAS NOTICED AFTER THE SURGERY THAT THE 0857-100 CAPTURING ROD AND 1192-100 LEFTY TIGHTY LAG SCREW GOT STUCK TOGETHER. ADDITIONAL INFORMATION RECEIVED ON 10/4/2024: THIS OCCURRED DURING A REVISION SURGERY. THE SCREW HAD COLLAPSED ALL THE WAY AND ENDED UP CUTTING THROUGH THE HEAD. ALL PRODUCTS WERE REMOVED, AND THE CASE WAS COMPLETED AS A TOTAL HIP PROCEDURE. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2024. BOTH SURGERIES WERE PERFORMED AT THE SAME FACILITY AND BY THE SAME SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2557122 LEFTY TIGHTY LAG SCREW, Ø10.5MMX100MM INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. LEFTY TIGHTY LAG SCREW, Ø10.5MMX100MM 230094 00848665036558

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other