BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO LAG SCREW, RIGHT, Ø10.5MMX100MM

    MDR report key: 15310509 · Received August 29, 2022

    Report

    Report Number
    1220246-2022-05412
    Event Type
    Malfunction
    Date Received
    August 29, 2022
    Date of Event
    June 3, 2022
    Report Date
    October 13, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665015850
    PMA / PMN Number
    K120148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER PROVIDED X-RAYS, WHICH DISPLAY THE LAG SCREW OUTSIDE OF THE FEMUR. WITHOUT RETURN OF THE DEVICE FOR PHYSICAL EVALUATION, THE CAUSE REMAINS UNDETERMINED. NO CHANGE IN HARM WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE LOCKING RING IS SPACED, INDICATING THAT IT HAD BEEN LOCKED INTO PLACE. THERE WERE ALSO MARKINGS ON THE GREY SLEEVE OF THE SCREW INDICATING THAT IT HAD BEEN USED. IT WAS ALSO NOTED THAT THE BLUE ACTIVATION SLEEVE IS STILL PRESENT WITHIN THE SCREW. WITHOUT REMOVAL OF THE ACTIVATION SLEEVE, THE DEVICE WILL NOT ALLOW FOR POST OPERATIVE COMPRESSION. THE COMPLAINT IS CONFIRMED BASED ON THE PROVIDED X-RAYS SHOWING THAT THE DEVICE BACKED OUT, HOWEVER THIS CAN BE ATTRIBUTED TO MISUSE BY THE END USER AS THE ACTIVATION SLEEVE WAS NOT REMOVED.

    Description of Event or Problem · 0

    ON 6/16/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT ON (B)(6) 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 08/08/2022, 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
    2455140 GALILEO LAG SCREW, RIGHT, Ø10.5MMX100MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ARTHREX, INC. GALILEO LAG SCREW, RIGHT, Ø10.5MMX100MM 211483 00848665015850

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other