BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO® CAPTURING ROD NUT

    MDR report key: 21585854 · Received March 12, 2025

    Report

    Report Number
    1220246-2025-00901
    Event Type
    Malfunction
    Date Received
    March 12, 2025
    Date of Event
    February 25, 2025
    Report Date
    June 27, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665039160
    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

    ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED 5046-100 LAG SCREW CAPTURING ROD NUT BATCH NUMBER: 220989 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED SUPERFICIAL WEAR AND TEAR TO THE DEVICE WITH SCRATCHES AND FADED LASER MARKINGS OBSERVED. THE MOST LIKELY CAUSE FOR THIS CAN BE ATTRIBUTED TO WEAR AND TEAR INCURRED THROUGH EXTENDED USE IN THE FIELD/REPEATED REPROCESSING. MANUFACTURED DATE: 12-OCT-2022. IT WAS FURTHER NOTED THAT THE 5046-100 LAG SCREW CAPTURING ROD NUT HAD BEEN IMPROPERLY THREADED ONTO THE 5033-100 CAPTURING ROD AND THE DEVICES COULD NOT BE SEPARATED. 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.

    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
    1112801 GALILEO® CAPTURING ROD NUT INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. GALILEO® CAPTURING ROD NUT 220989 00848665039160

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown