BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO® LAG SCREW INSERTER

    MDR report key: 23337638 · Received October 20, 2025

    Report

    Report Number
    1220246-2025-04699
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    October 9, 2025
    Report Date
    November 13, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    PMA / PMN Number
    K202099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, D1, D2A, D2B, D4, G3, G4, H6. BASED ON PHOTOGRAPHIC EVIDENCE OF THE 5030-000 GALILEO LAG SCREW INSERTER (LOT 220342), NO VISIBLE ISSUES WERE IDENTIFIED WITH THE DEVICE. ADDITIONALLY, NO DAMAGE OR BREAKAGE WAS REPORTED, AND A SECOND LAG SCREW WAS SUCCESSFULLY INSERTED USING THE SAME INSTRUMENT WITHOUT COMPLICATION. THESE FINDINGS INDICATE THAT THE INSERTER FUNCTIONED AS INTENDED. THE REPORTED ISSUE APPEARS TO BE RELATED TO THE LAG SCREW ITSELF OR THE INSERTION TECHNIQUE, RATHER THAN THE INSTRUMENT. NO PROBLEM WAS FOUND WITH THE 5030-000 INSERTER.

    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

    ADDITIONAL INFORMATION WAS RECEIVED ON 10/17/2025: DURING THE INSERTION OF AN AR-9094-100L TELESCOPING LAG SCREW, LEFT THREADED (10.5 X 100MM), THE EXTERNAL THREAD PITCHES STRIPPED OFF THE SCREW INDIVIDUALLY UPON REMOVAL. THE SCREW WAS ADVANCED USING THE 5030-000 GALILEO LAG SCREW INSERTER (BLUE HANDLE). NO DAMAGE OR BREAKAGE WAS REPORTED TO THE INSERTER, AS ANOTHER SCREW WAS SUBSEQUENTLY LOADED AND INSERTED WITHOUT ISSUE. ALL FRAGMENTS OF THE AR-9094-100L TELESCOPING LAG SCREW WERE SUCCESSFULLY RETRIEVED. RETRIEVAL OF THE BROKEN PIECES DELAYED THE PROCEDURE BY APPROXIMATELY 30 MINUTES. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO INSTRUMENT WAS USED TO TAP PRIOR TO INSERTION. THE SITE WAS DRILLED, AND THE IMPLANT WAS INSERTED. A SECOND AR-9094-100L TELESCOPING LAG SCREW (LOT: 230952) WAS USED WITHOUT ISSUE TO COMPLETE THE CASE. NO ADVERSE EFFECTS WERE REPORTED DURING OR FOLLOWING THE SURGERY. ADDITIONAL INFORMATION WAS RECEIVED ON 10/27/2025: IT WAS CONFIRMED VIA EMAIL THAT THE LEFT-THREADED LAG SCREW, WHICH COULD NOT ADVANCE AND HAD THE EXTERNAL THREAD PITCHES STRIPPED OFF THE SCREW INDIVIDUALLY DURING INSERTION, WAS THE 1192-100 LEFTY TIGHTY LAG SCREW, Ø10.5 MM X 100 MM, FROM LOT 212124.

    Description of Event or Problem · 0

    ON 10/10/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN UNKNOWN ARTHREX PRODUCT EXPERIENCED AN ISSUE DURING USE WITH A TROCHANTERIC NAIL SYSTEM DURING AN INTERTROCHANTERIC FRACTURE PROCEDURE PERFORMED ON (B)(6) 2025. THE LEFT-THREADED LAG SCREW WAS PROPERLY LOADED AND INSERTED INTO THE PATIENT. THE SCREW WAS ADVANCED USING THE BLUE HANDLE DRIVER, TURNED COUNTERCLOCKWISE IN ACCORDANCE WITH THE TECHNIQUE GUIDE AND THE LEFT-HAND THREAD PITCH OF THE SCREW. DURING INSERTION, THE SCREW BEGAN TO STRUGGLE TO ADVANCE. DESPITE MULTIPLE ATTEMPTS AND ROTATIONS, THE SCREW WOULD NOT PROGRESS. UPON BACKING OUT THE LAG SCREW, IT WAS OBSERVED THAT THE EXTERNAL THREAD PITCHES HAD STRIPPED OFF THE SCREW INDIVIDUALLY. LOCATING AND REMOVING THE STRIPPED THREADS REQUIRED AN EXTENDED PERIOD OF TIME. AFTER ALL THREADS WERE SUCCESSFULLY REMOVED, A SECOND LEFT-THREADED LAG SCREW WAS LOADED AND ADVANCED WITHOUT ISSUE, AND THE CASE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 10/14/2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2283975 GALILEO® LAG SCREW INSERTER INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. 5030-000 220342

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown