BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVL ANGLED REAMER SLEEVE ASSEMBLY, 15

    MDR report key: 19201692 · Received April 29, 2024

    Report

    Report Number
    1220246-2024-02538
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    April 4, 2024
    Report Date
    June 13, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867350038
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    COMPLAINT IS CONFIRMED. ONE UNPACKAGED AR-9297-15 ANGLED REAMER SLEEVE LOT NUMBER: 052224 WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION NOTED THAT THERE WAS AN AR-9676 ANGLED REAMER DRIVESHAFT UNKNOWN BATCH NUMBER STUCK INSIDE THE ANGLE REAMER SLEEVE. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THERE BEING AN AR-9676 ANGLED REAMER SHAFT STUCK INSIDE THE DEVICE THAT CANNOT BE REMOVED. THE MOST LIKELY CAUSE IS ATTRIBUTED TO MISUSE DUE TO INTERFERENCE WITH THE MATING INSTRUMENT. REFER TO THE INVESTIGATION PHOTOS. COMPLAINT IS CONFIRMED.

    Description of Event or Problem · 0

    ON 4/04/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9297-15 ANGLED REAMER IS DAMAGED (NON-SPECIFICALLY). THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420507 AVL ANGLED REAMER SLEEVE ASSEMBLY, 15 ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. AVL ANGLED REAMER SLEEVE ASSEMBLY, 15 UNK 00888867350038

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown