BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERS REVERS VERSION ROD

    MDR report key: 20795674 · Received November 27, 2024

    Report

    Report Number
    1220246-2024-08650
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    November 7, 2024
    Report Date
    January 28, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867061620
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-9510-01 ARTHREX UNIVERS REVERS¿ VERSION ROD, SERIAL/BATCH NUMBER (B)(6), WAS RECEIVED FOR EVALUATION. THE DEVICE ARRIVED FOR EVALUATION SEPARATED FROM THE AR-9510-02. VISUAL INSPECTION REVEALED THAT THE THREADED TIP OF THE DEVICE WAS BROKEN OFF. THE EVALUATION OF THE THREADED TIP DISCOVERED NICKS AND BENDS IN THE THREADS. FUNCTIONAL TESTING WAS NOT PERFORMED AS THE DEVICE IS DAMAGED. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR, SPECIFICALLY APPLYING EXCESSIVE FORCE THROUGH LEVERAGING OR PRYING THE DEVICE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, D9, G3.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    UPDATE KPILZ 03-DEZ-2024: FURTHER INFORMATION WERE RECEIVED THAT THE DEVICE BROKE DURING A SHOULDER PROTHESIS SURGERY. THE DEVICE BROKE OUTSIDE OF THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGERY THE DEVICE BROKE. THE DEVICE IS STILL STUCK IN THE DEVICE AR-9510-2, BATCH: 052246-R. THE SURGERY WAS FINISHED SUCCESSFULLY. NO FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2368195 UNIVERS REVERS VERSION ROD ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. UNIVERS REVERS VERSION ROD 250225102 00888867061620

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown