BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER, DRIVE SHAFT

    MDR report key: 20195003 · Received September 11, 2024

    Report

    Report Number
    1220246-2024-07533
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    August 14, 2024
    Report Date
    October 1, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867324954
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-9676, BATCH 022339, WAS RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, SCRATCH MARKS WERE OBSERVED AT BOTH THE DISTAL AND PROXIMAL ENDS OF THE DEVICE, SUGGESTING SIGNS OF FRICTION. DURING FUNCTIONAL TESTING, THE DEVICE EXPERIENCES RESISTANCE AND FRICTION WHEN THE MATING COMPONENT IS INTEGRATED INTO THE AR-9597-10. THE MOST LIKELY REASON FOR THE REPORTED FAILURE IS THE WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE.

    Description of Event or Problem · 0

    ON 08/14/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT (QTY. (B)(6) OF AN AR-9597-10 ANGLED REAMER SLEEVE FUSED TO THE OUTER SLEEVE OF (QTY. (B)(6) OF AN AR-9676 ANGLED REAMER, DRIVE SHAFT DURING REAMING OF THE GLENOID. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT, BUT THE SURGEON'S WRIST HURT WHEN THE DRILL STARTED SPINNING FOR THE TWO SETS OF INSTRUMENTS. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1593269 ANGLED REAMER, DRIVE SHAFT MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER, DRIVE SHAFT 022339 00888867324954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown