BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR PAD

    MDR report key: 19632471 · Received June 28, 2024

    Report

    Report Number
    1220246-2024-06492
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Date of Event
    May 31, 2024
    Report Date
    September 23, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00848665013559
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    ONE UNPACKAGED 0837-000 IMPACTOR PAD LOT NUMBER: 210546 WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION OF THE DEVICE NOTED SIGNIFICANT WEAR AND TEAR DAMAGE, WITH MULTIPLE DENTS AND SCRATCHES ON THE SURFACE AND SLIGHT DISCOLORATION OF THE DEVICE ALONG WITH FADED LASER MARKINGS. THE MOST LIKELY CAUSE FOR THIS CAN BE ATTRIBUTED TO WEAR AND TEAR INCURRED FROM REPEATED USE. MANUFACTURED DATE: 28-JUN-2021. THE COMPLAINT DEVICE WAS FURTHER VISUALLY INSPECTED UNDER A MAGNIFIER AND DAMAGE WAS NOTED TO THE THREAD OF THE DEVICE. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR DUE TO EXCESSIVE FORCE/FRICTION DURING USE. COMPLAINT ALLEGATION IS CONFIRMED.

    Description of Event or Problem · 0

    ON 5/31/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT A 0812-100 EASYOUT EXTRACTOR AND AN 0837-000 IMPACTOR PAD WERE THREADED INTO THE EXTRACTION TOOL, AND WHEN THE SURGEON WAS REMOVING THE IMPLANT, METAL SHAVINGS WERE EVERYWHERE FROM BOTH PIECES. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 6/4/2024: THE METAL SHAVINGS DID NOT GO INSIDE THE PATIENT BUT JUST INTO THE STERILE FIELD. ALL METAL SHAVINGS WERE REMOVED FROM THE STERILE FIELD, AND THE CASE WAS COMPLETED. THERE WAS NO CASE DELAY. THIS WAS DISCOVERED DURING A TIBIAL NAIL REMOVAL PROCEDURE. THE ISSUE HAD NO ADVERSE EFFECTS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2215544 IMPACTOR PAD MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. IMPACTOR PAD 210546 00848665013559

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown