BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ES¿ TROCH NAIL, LEFT, Ø11MMX39CMX130°

    MDR report key: 20522263 · Received October 24, 2024

    Report

    Report Number
    1220246-2024-08233
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    September 3, 2024
    Report Date
    December 24, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665015164
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    NO ALLEGATIONS WERE IDENTIFIED AGAINST THE 1058-395 ES¿ TROCHANTERIC NAIL, LEFT, 11MM X 39CM X 130º SERIAL/BATCH NUMBER 211326; HOWEVER, THE RETURNED DEVICE WAS DAMAGED. ONE UNPACKAGED 1058-395 ES¿ TROCHANTERIC NAIL, LEFT, 11MM X 39CM X 130º SERIAL/BATCH NUMBER 211326 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED SCRATCHES AND GEOMETRY LOSS DUE TO A BENT IN THE HOLE WHERE THE LAG SCREW IS SET. THE OBSERVED DAMAGE IS MOST LIKELY CAUSED BY EXCESSIVE FORCE APPLICATION OR MISALIGNMENT DURING REMOVAL. A DAMAGED THREAD WAS ALSO NOTED ON THE CONNECTOR HOLE AT THE PROXIMAL END. THIS WAS MOST LIKELY CAUSED BY USER ERROR. WHEN TWO DEVICES ARE INTENDED TO BE THREADED/MATED TOGETHER, ENSURE THEY ARE FULLY ENGAGED BEFORE USE.

    Description of Event or Problem · 0

    ON 09/03/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A 5033-100 CAPTURING ROD ASSEMBLY WAS COLD-WELDED WITH THE SCREW. THIS OCCURRED DURING A REVISION TROCH NAIL PROCEDURE WHEN THE SURGEON REMOVED OUR TROCH NAIL AND IMPLANTED A SYNTHES NAIL WHEN THE GALILEO CAPTURING ROD COLD WELDED TO THE SCREW UPON REMOVAL.

    Description of Event or Problem · 0

    ON 9/10/2024 ADDITIONAL INFORMATION WAS RECEIVED BY A SALES REPRESENTATIVE VIA EMAIL WHO STATED THAT THE PROCEDURE PERFORMED WAS A SUBTROCHANTERIC HIP FRACTURE. THE LAG SCREW BROKE IN THE PATIENT'S FEMORAL HEAD. THE DATE OF THE INITIAL PROCEDURE WAS (B)(6) 2024. A PICTURE ATTACHED SHOWS ALL THE PARTS USED IN THE INITIAL PROCEDURE. AN ARTHREX REP WAS PRESENT. A STANDARD 10.3 DRILL IN THE TORCH NAIL SET WAS USED TO PREPARE THE BONE SOCKET FOR INSERTION. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. TO COMPLETE THE PROCEDURE, A STANDARD REMOVAL INSTRUMENTATION FOR THE LATERAL BODY OF THE LAG SCREW. THE SURGEON USED A CONICAL EXTRACTOR FROM THE AOS 7.0 SCREW SET AND REMOVED THE PURPLE BROKEN SCREW THREADS HALFWAY AND THEN BENT A 2.0 K WIRE INTO THE CANNULA OF THE SCREW AND REMOVED FROM THE FEMORAL HEAD. IT WAS UNKNOWN IF THERE WERE DELAYS OR IF ADDITIONAL ANESTHESIA WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2565907 ES¿ TROCH NAIL, LEFT, Ø11MMX39CMX130° INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. ES¿ TROCH NAIL, LEFT, Ø11MMX39CMX130° 211326 00848665015164

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other