BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER, ORIENTATION SLEEVE

    MDR report key: 21960409 · Received May 5, 2025

    Report

    Report Number
    1220246-2025-01881
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    April 17, 2025
    Report Date
    August 6, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867324909
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    501

    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. ONE UNPACKAGED AR-9679, BATCH 051946, WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED THAT THE HANDLE WAS CRACKED. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS WEAR AND TEAR. DUE TO CONTINUOUS MECHANICAL FORCES APPLIED TO IT, THE DEVICE WILL INEVITABLY SUSTAIN DAMAGE OVER TIME. REFER TO INVESTIGATION PHOTOS. THE COMPLAINT ALLEGATION IS CONFIRMED.

    Description of Event or Problem · 0

    ON 04/17/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9679 ORIENTATION SLEEVE, ANGLED REAMER WAS BROKEN. THIS WAS DISCOVERED IN A CASE WITH NO ADVERSE EFFECTS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500895 ANGLED REAMER, ORIENTATION SLEEVE MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER, ORIENTATION SLEEVE 00888867324909

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown