BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALILEO LAG SCREW, RIGHT, Ø10.5MMX95MM

    MDR report key: 20522252 · Received October 24, 2024

    Report

    Report Number
    1220246-2024-08232
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    February 21, 2024
    Report Date
    December 20, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665015843
    PMA / PMN Number
    K120148
    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

    ADDITIONAL INFORMATION: B4, B5, G3, H6.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED 1099-095 TELESCOPING LAG SCREW, 10.5MM X 95MM SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR EVALUATION. THE DEVICE WAS RECEIVED WITH THE 5033-100 GALILEO® CAPTURING ROD BATCH 212533 STUCK INSIDE. VISUAL INSPECTION REVEALED THAT THE TELESCOPING LAG SCREW WHICH WAS BROKEN AT THE DISTAL END SEPARATING THE THREADED SHAFT FROM THE BARREL. MULTIPLE SCRATCHES WERE NOTED ON THE BARREL, THE LOCKING RING, AND THE LOCKING SLEEVE. THE MORE IN-DEPTH VISUAL EVALUATION REVEALED THAT THE BARREL TEETH WERE BENT. EVALUATION OF THE THREADED SHAFT REVEALED NICKS AT THE THREADS. THE DEVICE WAS RECEIVED WITH A METAL GUIDE STUCK INSIDE THE THREADED ROD, WHICH WAS BENT. NO ALLEGATION AGAINST THE METAL GUIDE STUCK INSIDE THE PIECE OF THE THREADED ROD OF THE TELESCOPING LAG SCREW WAS RECEIVED. THE MOST LIKELY CAUSE(S) OF THE REPORTED FAILURE IS USER ERROR, EXCESSIVE FORCE APPLICATION, OR MISALIGNMENT DURING THE REMOVAL PROCESS.

    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
    2562207 GALILEO LAG SCREW, RIGHT, Ø10.5MMX95MM INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. GALILEO LAG SCREW, RIGHT, Ø10.5MMX95MM 212633 00848665015843

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other