BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVN DISPOSABLES KIT

    MDR report key: 18960417 · Received March 22, 2024

    Report

    Report Number
    1220246-2024-01636
    Event Type
    Malfunction
    Date Received
    March 22, 2024
    Date of Event
    March 7, 2024
    Report Date
    September 3, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867266643
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-3519H SERIAL/BATCH NUMBER 0072249 WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE TIP OF THE DEVICE. VISUAL INSPECTION NOTED THAT THE CANNULATED REAMER, GUIDE PIN AND PLUNGER WERE NOT RETURNED FOR EVALUATION. THE CUTTING BLADE OF THE EXPANDABLE REAMER WAS NOT RETRACTING. THE MOST LIKELY CAUSE IS ATTRIBUTED TO MISUSE DUE TO PRYING/LEVERAGING THE DEVICE 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

    IT WAS REPORTED THAT DURING AN HIP AVASCULAR NECROSIS (AVN) SURGERY WITH BMAC AND INNOTERE THE BLADE DEPLOYED WHEN IT WAS NOT SUPPOSED TO. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (5 MM REAMER). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 13-MAR-2024 IT WAS CONFIRMED THAT THE BLADE PUSHED OUT EVERY TIME THE SURGEON PUT PRESSURE ON THE BACK OF THE DEVICE. IT WAS DIFFICULT TO ADVANCE THE DEVICE WITHOUT PLACING PRESSURE ON THE BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524687 AVN DISPOSABLES KIT ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. AVN DISPOSABLES KIT 15063239 00888867266643

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown