BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAV FRAC PLT,CENTRAL THIRD,LFT,SS

    MDR report key: 9287048 · Received November 6, 2019

    Report

    Report Number
    1220246-2019-01396
    Event Type
    Injury
    Date Received
    November 6, 2019
    Date of Event
    July 5, 2019
    Report Date
    April 23, 2020
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON 12/10/2019: THE SALES REP PROVIDED THE SALES ORDER FROM THE ORIGINAL ON (B)(6) 2019 PROCEDURE AND THE REVISION ON (B)(6) 2019 REVISION PROCEDURE. THE FOLLOWING ARTHREX PRODUCTS WERE USED DURING THE PRIMARY ON (B)(6) 2019 CLAVICLE FRACTURE PROCEDURE: AR-2653CL // LOT: 6791238 // QTY.: 1. AR-8835-12 // LOT: 10227335 // QTY.: 2. AR-8835-14 // LOT: 10273287 // QTY.: 1. AR-8835-14 // LOT: 10285356 // QTY.: 1. AR-8835L-14 // LOT: 10224996 // QTY.: 1. AR-8835L-14 // LOT: 10231440 // QTY.: 1. AR-8835L-14 // LOT: 10240975 // QTY.: 2. AR-8835L-16 // LOT: 031740 // QTY.: 1. AR-8835L-16 // LOT: 10188573 // QTY.: 1. AR-8943-13 // LOT: 1391830 // QTY.: 1. THE FOLLOWING ARTHREX PRODUCTS WERE USED DURING THE REVISION ON (B)(6) 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 12/12/2019: THE SALES REP REPORTED ALL DEVICES THAT WERE ORIGINALLY IMPLANTED DURING ON (B)(6) 2019 PRIMARY PROCEDURE WERE EXPLANTED DURING ON (B)(6) 2019 REVISION PROCEDURE. 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.

    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 REPORTED THAT THE PATIENT HAD A PRIMARY CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2019 IN WHICH AR-2653CL / LOT: 6791238 WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT STARTED EXPERIENCING PAIN AND DISCOMFORT, AND HAD A FOLLOW-UP VISIT WITH THEIR SURGEON. X-RAYS WERE TAKEN DURING THE FOLLOW-UP VISIT, AND CONFIRMED THE IMPLANTED AR-2653CL HAD BENT. ON (B)(6) 2019 A REVISION PROCEDURE WAS PERFORMED BY THE SAME SURGEON AT A NEIGHBORING FACILITY. THE AR-2653CL ALONG WITH A TOTAL OF TEN SCREWS (PART AND LOT NUMBERS UNKNOWN) WERE REMOVED. THE PATIENT STATED THEY HAVE ALL EXPLANTED DEVICES IN THEIR POSSESSION. THE PATIENT BELIEVES THEY HAD ANOTHER AR-2653CL (LOT UNKNOWN) IMPLANTED DURING THE REVISION PROCEDURE, BUT THEY CANNOT CURRENTLY CONFIRM WHAT DEVICES WERE IMPLANTED DURING THE REVISION. ON (B)(6) 2019 THE PATIENT STARTED EXPERIENCING PAIN AND DISCOMFORT, AND RECOGNIZED THAT THEIR CLAVICLE HAD MOVED AND THEIR SKIN WAS TENTING. A THIRD PROCEDURE HAS NOT YET BEEN SCHEDULED, AND X-RAYS HAVE NOT BEEN TAKEN. THE PATIENT STATED THEY HAVE BEEN COMPLIANT, AND THEIR PAIN STARTED AFTER AND DURING REHABILITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078099 CLAV FRAC PLT,CENTRAL THIRD,LFT,SS PLATE, FIXATION, BONE HRS ARTHREX, INC. CLAV FRAC PLT,CENTRAL THIRD,LFT,SS 6791238 00888867027442

    Patients

    Seq Age Sex Outcome Treatment
    1 Other