BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAV FRAC PLT,CENTRAL THIRD,LFT,SS

    MDR report key: 17465823 · Received August 4, 2023

    Report

    Report Number
    1220246-2023-07438
    Event Type
    Injury
    Date Received
    August 4, 2023
    Date of Event
    May 2, 2023
    Report Date
    October 18, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867027428
    PMA / PMN Number
    K143139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 NOT CONFIRMED. ONE UNPACKAGED AR-2652CL WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED THAT THE RETURNED AR-2652CL IS NOT BROKEN. THE DEVICE SHOWS A NICK UNDER THE "LEFT" LASER ETCH. FUNCTIONAL TESTING IDENTIFIED THAT THE RETURNED DEVICE WORKS AS REQUIRED WITH THE MATTING ARTHREX SCREWS. NO PROBLEM FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ARTHREX PLATE BROKE AFTER THE IMPLANTATION. NO FURTHER INFORMATION RECEIVED. (B)(6) 2023 UPDATE DW. FURTHER INFORMATION WERE PROVIDED THAT THE BROKEN PLATE WAS AN AR-2652CL WITH THE BATCH 5261949. IT WAS FURTHER REPORTED THAT THE FOLLOWING DEVICES WERE EXPLANTED AS WELL: 2X AR-8835L-14 BATCH 10732033, 2X AR-8835-14 BATCH 10732033, 1X AR-8827-18 BATCH 1071964, 1X THIRD-PARTY IMPLANT. (B)(6) 2023 UPDATE DW. FURTHER INFORMATION WERE PROVIDED THAT A REVISION SURGERY WAS PERFORMED WITH A DEVICE FROM ANOTHER MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1660078 CLAV FRAC PLT,CENTRAL THIRD,LFT,SS WASHER, BOLT, NUT HRS ARTHREX, INC. CLAV FRAC PLT,CENTRAL THIRD,LFT,SS 5261949 00888867027428

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown