BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO® TROCH NAIL, Ø11MMX20CMX125°

    MDR report key: 15310497 · Received August 29, 2022

    Report

    Report Number
    1220246-2022-05411
    Event Type
    Malfunction
    Date Received
    August 29, 2022
    Date of Event
    June 3, 2022
    Report Date
    November 14, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665014655
    PMA / PMN Number
    K021008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    501

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    COMPLAINT NOT CONFIRMED. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE DEVICE IS SCRATCHED/DAMAGED NEAR THE TOP. NO FUNCTION PROBLEM WAS NOTED WITH THE DEVICE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT ON 6/3/2022, A PATIENT UNDERWENT SURGERY FOR A TROCHANTERIC FRACTURE AND AN ARTHREX SHORT TROCHANTERIC NAIL WAS IMPLANTED. TWELVE DAYS POST OPERATIVE, WHILE TRYING TO STAND FROM THE WHEELCHAIR, PATIENT FELT LIKE THE NAIL HAD EXPLODED OUT OF THE LEG. X-RAYS WERE TAKEN OF THE IMPLANTS AND WHILE IT IS STILL UNKNOWN WHAT HAPPENED, IT SEEMS LIKE THE LOCKING RING WAS NOT ABLE TO HOLD THE LAG SCREW IN PLACE. AS OF NOW, THE SURGEON IS NOT PLANNING ON A REVISION SURGERY AND WILL FOLLOW UP AGAIN WITH THE PATIENT IN TWO WEEKS. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2022, IT WAS REPORTED THAT ANOTHER 4 WEEK POST OP OCCURRED ON (B)(6) 2022 AND X-RAYS SHOWED THAT THE NAIL HAD FURTHER BACKED OUT. A REVISION SURGERY TOOK PLACE ON (B)(6) 2022, AT THIS TIME THE 1031-200 GALILEO® TROCH NAIL,1099-100 GALILEO LAG SCREW, AND 8001-036 CAPTURED CORTICAL SCREW WERE EXPLANTED. THE SURGEON CONVERTED TO A TOTAL HIP ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2393138 GALILEO® TROCH NAIL, Ø11MMX20CMX125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ARTHREX, INC. GALILEO® TROCH NAIL, Ø11MMX20CMX125° 160771 00848665014655

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other