BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVERS BROACH/TRIAL, SIZE 5 MODULAR

    MDR report key: 21755166 · Received April 2, 2025

    Report

    Report Number
    1220246-2025-01189
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    March 11, 2025
    Report Date
    September 3, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867354319
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. THE REPORTED EVENT IS CONFIRMED. THE VISUAL EVALUATION OF THE AR-9510-05MDM, BATCH 111970 REVEALED THAT THE HALF OF THE SNAP-IN EDGE IS WORN (SEE EVALUATION PICTURES 2 - 4). THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE IS THE WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A REVERS TOTAL SHOULDER ARTHROPLASTY THE SIZE 5 BROACH CHIPPED OFF. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE (SIZE 5 BROACH). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2301920 REVERS BROACH/TRIAL, SIZE 5 MODULAR ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. REVERS BROACH/TRIAL, SIZE 5 MODULAR 111970 00888867354319

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown