BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPTURED CORTICAL SCREW, Ø5.0MM X 36MM

    MDR report key: 15310510 · Received August 29, 2022

    Report

    Report Number
    1220246-2022-05413
    Event Type
    Injury
    Date Received
    August 29, 2022
    Date of Event
    June 3, 2022
    Report Date
    August 29, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665019131
    PMA / PMN Number
    K132005
    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 PHOTO, WHICH DISPLAYS THE NAIL STICKING OUT OF THE HEAD OF THE FEMUR. HOWEVER, WITHOUT RETURN OF THE DEVICE FOR PHYSICAL EVALUATION, THE CAUSE REMAINS UNDETERMINED. NO CHANGE IN HARM WAS IDENTIFIED.

    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
    2455141 CAPTURED CORTICAL SCREW, Ø5.0MM X 36MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ARTHREX, INC. CAPTURED CORTICAL SCREW, Ø5.0MM X 36MM 211565 00848665019131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other