BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO® EXTRACTION TOOL, CAPTURING ROD

    MDR report key: 19179675 · Received April 25, 2024

    Report

    Report Number
    1220246-2024-02350
    Event Type
    Malfunction
    Date Received
    April 25, 2024
    Date of Event
    April 1, 2024
    Report Date
    September 4, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665030891
    PMA / PMN Number
    K021008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED 0857-100 BATCH 221019 WAS RECEIVED FOR INVESTIGATION. THE DEVICE ARRIVED STUCK INSIDE THE PART NUMBER 1099-0090 BATCH 212625. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DEVICE ARRIVED STUCK INSIDE THE PART NUMBER 1099-0090. UPON VISUAL INSPECTION, DAMAGE TO THE SHAFT AND THE THREADED TIP WAS OBSERVED. IT WAS ALSO NOTED THAT THE DEVICE WAS BENT. THE MOST LIKELY CAUSE(S) OF THE REPORTED FAILURE ARE USER ERROR, MISALIGNED INSERTION, OR EXCESSIVE FORCE DURING USE.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2024, DURING DEVICE EVALUATION OF THE RETURNED DEVICE, IT WAS FOUND THAT THE 0857-100 WAS STUCK INSIDE A 1099-090 GALILEO LAG SCREW, RIGHT, Ø10.5MMX90MM.

    Description of Event or Problem · 0

    ON 04/01/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06529172 THAT AN 0857-100 GALILEO EXTRACTION TOOL WAS DAMAGED DURING THE CASE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1468101 GALILEO® EXTRACTION TOOL, CAPTURING ROD INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. GALILEO® EXTRACTION TOOL, CAPTURING ROD UNK 00848665030891

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown