BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAV FRAC PLT,CENTRAL THIRD,LFT,SS

    MDR report key: 17549799 · Received August 15, 2023

    Report

    Report Number
    1220246-2023-07508
    Event Type
    Injury
    Date Received
    August 15, 2023
    Date of Event
    May 2, 2023
    Report Date
    November 2, 2023
    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 COMPLAINT IS CONFIRMED. ONE UNPACKAGED AR-2652CL CLAVICLE FRACTURE PLATE, CENTRAL THIRD, LEFT, SS, BATCH 5262102, WAS RETURNED FOR INVESTIGATION. THE RETURNED DEVICE WAS VISUALLY INSPECTED, AND IT WAS NOTED THAT THE PLATE WAS BROKEN INTO TWO PIECES AT ONE OF THE COMPRESSION SLOTS CLOSE TO THE MIDDLE OF THE PLATE; BESIDES, A BENT WAS NOTED IN ONE OF THE COMPRESSION SLOTS CLOSE TO THE LOCKING HOLE. UPON FUNCTIONAL TESTING WITH THE RETURNED LOW-PROFILE AND THE LOW-PROFILE LOCKING SCREWS, IT WAS FOUND THAT ONLY THE LOW-PROFILE LOCKING SCREW SITS FLUSH AND THREADS ENTIRELY. THE OTHER RETURNED LOW-PROFILE SCREWS DO NOT FIT THE LOCKING OR COMPRESSION HOLES. THE FIT IS TOO LOOSE. THE METHOD OF BONE PREPARATION EMPLOYED DURING THE PROCEDURE, AS WELL AS THE BONE QUALITY ENCOUNTERED, WAS NOT PROVIDED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE IS A USER ERROR.

    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

    IT WAS REPORTED THAT THE SCREW HAS LOOSENED IN THE CLAVICLE PLATE. NO FURTHER INFORMATION RECEIVED. 27-JUN-2023 UPDATE DW: FURTHER INFORMATION WERE PROVIDED THAT THE FOLLOWING DEVICES BECAME LOOSE POST OP. AR-2652CL BATCH: 5262102, AR-8835L-14 BATCH: 15040867, AR-8835-14 BATCH: 10694746, 2X AR-8835-16 BATCH: 1072011, 3X AR-8835-18 BATCH: 10591283, AR-8827-14 BATCH: 1074240. AS THE REPORTED DEVICES ARE AVAILABLE FOR RETURN A REVISION SURGERY HAD TO BE PERFORMED BUT NO FURTHER INFORMATION WERE PROVIDED WHEN THE REVISION SURGERY WAS PERFORMED. 13-JUL-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
    994523 CLAV FRAC PLT,CENTRAL THIRD,LFT,SS WASHER, BOLT, NUT HRS ARTHREX, INC. CLAV FRAC PLT,CENTRAL THIRD,LFT,SS 5262102 00888867027428

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other