BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAV FRAC PLT,CENTRAL THIRD,LFT,SS

    MDR report key: 9519555 · Received December 26, 2019

    Report

    Report Number
    1220246-2019-01537
    Event Type
    Injury
    Date Received
    December 26, 2019
    Date of Event
    October 24, 2019
    Report Date
    December 26, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867027442
    PMA / PMN Number
    K143139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS PREVIOUSLY REPORTED THAT A PATIENT HAD A REVISION PROCEDURE ON (B)(6) 2019 DUE TO A BROKEN CLAVICLE PLATE (CASE (B)(4)). ON (B)(6) 2019 THE PATIENT STARTED EXPERIENCING PAIN AND DISCOMFORT, AND RECOGNIZED THAT THEIR CLAVICLE HAD MOVED AND THEIR SKIN WAS TENTING. THE PATIENT HAD A FOLLOW-UP VISIT WITH THEIR SURGEON ON (B)(6) 2019, AND THE X-RAYS TAKEN DURING THE FOLLOW-UP REVELED THE IMPLANTED HARDWARE HAD BROKEN. THE SECOND REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019. COPIES OF X-RAYS WERE PROVIDED AND HAVE BEEN ATTACHED TO THE COMPLAINT RECORD. THE ARTHREX PART AND LOT NUMBERS THAT WERE EXPLANTED AND IMPLANTED DURING THE (B)(6) 2019 REVISION PROCEDURE ARE CURRENTLY UNKNOWN. ADDITIONAL INFORMATION RECEIVED ON 12/12/2019: THE REP PROVIDED THE PART NUMBERS OF THE ARTHREX PRODUCT USED AND IMPLANTED DURING THE (B)(6) 2019 REVISION PROCEDURE. THE REP REPORTED ALL IMPLANTED ARTHEX PRODUCT WAS EXPLANTED DURING THE SECOND REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2019. THE PART NUMBERS OF DEVICES IMPLANTED DURING THE (B)(6) 2019 PROCEDURE IS STILL UNKNOWN AT THIS TIME. THE FOLLOWING ARTHREX PRODUCTS WERE USED DURING THE REVISION 07/05/2019 PROCEDURE; AR-2653CL // LOT: 5261824 // QTY.: 1, AR-8835-12 // LOT: 10227335 // QTY.: 1, AR-8835-12 // LOT: 10239798 // QTY.: 1, AR-8835-14 // LOT: 10285356 // QTY.: 2, AR-8835L-14 // LOT: 10293298 // QTY.: 1, AR-8835L-14 // LOT: 10298303 // QTY.: 3, AR-8835L-16 // LOT: 10223166 // QTY.: 2. ADDITIONAL INFORMATION RECEIVED ON 12/13/2019: THE SALES REP REPORTED NO EXPLANTED DEVICES ARE AVAILABLE TO RETURN, AND THE SAME ARTHREX SALES REPRESENTATIVE WAS PRESENT FOR ALL PROCEDURES. THE REP REPORTED THE SURGEON USED ACCUMED PLATING SYSTEM IN THE (B)(6) 2019 PROCEDURE. SUPERIOR AND ANTERIOR ACCUMED PLATES WERE USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313529 CLAV FRAC PLT,CENTRAL THIRD,LFT,SS PLATE, FIXATION, BONE HRS ARTHREX, INC. CLAV FRAC PLT,CENTRAL THIRD,LFT,SS 5261824 00888867027442

    Patients

    Seq Age Sex Outcome Treatment
    1 Other