BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER, DRIVE SHAFT

    MDR report key: 19233425 · Received May 2, 2024

    Report

    Report Number
    1220246-2024-02724
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Date of Event
    April 9, 2024
    Report Date
    June 10, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867324954
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H6. THE COMPLAINT IS CONFIRMED. ONE UNPACKAGED AR-9676 / BATCH 022304 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION FOUND NICKS AND ABRASION MARKS AROUND THE REAMER'S SHAFT. FUNCTIONAL TESTING REVEALED THAT THE DEVICE DID NOT ROTATE FREELY IN THE AR- 9597-20 DUE TO THE ABRASION MARKS AROUND IT. THE MOST LIKELY CAUSE IS ATTRIBUTED TO MISUSE DUE TO INTERFERENCE WITH THE MATING INSTRUMENT.

    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

    ON 04/09/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9597-20 ANGLED REAMER SLEEVE AND AN AR-9676 ANGLED REAMER WERE INCARCERATED TOGETHER. THIS WAS DISCOVERED AFTER A CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857587 ANGLED REAMER, DRIVE SHAFT MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER, DRIVE SHAFT 022304 00888867324954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown