BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO® CAPTURING ROD

    MDR report key: 19509622 · Received June 11, 2024

    Report

    Report Number
    1220246-2024-05538
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    April 28, 2023
    Report Date
    June 11, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665039177
    PMA / PMN Number
    K202099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING DUE TO DAMAGE TO THE DEVICE.

    Description of Event or Problem · 0

    ON 5/5/2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A 5033-100 CAPTURING ROD ASSEMBLY BROKE WHEN INSERTING A TELESCOPING LAG SCREW. THE CASE WAS COMPLETED BY REMOVING THE 1099-120 TELESCOPING LAG SCREW, 8001-055 CAPTURED CORTICAL SCREW, AND 8021-080 CANCELLOUS A/R SCREW AND USING NEW ONES WITH A NEW INSTRUMENT SET. THIS WAS DISCOVERED DURING A FEMUR INTRAMEDULLARY NAILING PROCEDURE ON (B)(6) 2023. NOTHING BROKE INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089792 GALILEO® CAPTURING ROD ORTHOPEDIC MANUAL SURG INSTR HSB ARTHREX, INC. GALILEO® CAPTURING ROD UNK 00848665039177

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown