BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO® CAPTURING ROD

    MDR report key: 21593298 · Received March 13, 2025

    Report

    Report Number
    1220246-2025-00911
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 25, 2025
    Report Date
    July 8, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665039177
    PMA / PMN Number
    K202099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED 5033-100 CAPTURING ROD BATCH NUMBER: 220097 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED THAT A 5046-100 LAG SCREW CAPTURING ROD NUT HAD BEEN IMPROPERLY THREADED ONTO THE RETURNED 5033-100 CAPTURING ROD AND THE DEVICES COULD NOT BE SEPARATED. IT WAS FURTHER NOTED THAT THE THREADS WHERE THE LAG SCREW MATES WERE ALSO DAMAGED. FUNCTIONAL TESTING WAS NOT ABLE TO BE PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE DUE TO USE ERROR WHEN THREADING THE MATING DEVICES. REFER TO INVESTIGATION PHOTOS.

    Description of Event or Problem · 0

    ON 02/25/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A 5046-100 LAG SCREW CAPTURING ROD NUT AND A 5033-100 CAPTURING ROD ASSEMBLY HAD AN ISSUE WITH NOT LOCKING THE LAG SCREW INTO THE NAIL AS DESIGNED AND HAD TO USE THE LOCKING END CAP INSTEAD. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699627 GALILEO® CAPTURING ROD INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. GALILEO® CAPTURING ROD 220097 00848665039177

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown