BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET

    MDR report key: 7788214 · Received August 16, 2018

    Report

    Report Number
    1220246-2018-00596
    Event Type
    Injury
    Date Received
    August 16, 2018
    Date of Event
    July 23, 2018
    Report Date
    August 16, 2018
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867193925
    PMA / PMN Number
    K150648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 DEVICE WAS REPORTED TO HAVE BEEN DISCARDED BY THE FACILITY. THE 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 A REVISION SURGERY TOOK PLACE ((B)(6) 2018) FOR A FAILED INTEROSSEOUS SL RECONSTRUCTION THAT TOOK PLACE ON (B)(6) 2018. THE REP STATED THAT THE PATIENT WAS FEELING PAIN AND INSTABILITY POST-SURGERY. X-RAYS REVEALED THAT THE AR-8978P (LOT: F192202) ORIGINALLY IMPLANTED ON 05/21/18 WAS NO LONGER IN THE BONE AND FLOATING IN THE JOINT CAUSING THE WHOLE CONSTRUCT TO FAIL. THE SURGEON DECIDED TO REMOVE THE PROXIMAL ROW OF CARPAL BONES IN FEAR OF ANOTHER FAILURE. AFTER REMOVING THE ANCHOR FROM THE JOINT, IT WAS NOTICED THAT THE TIP OF THE AR-8978P WAS BENT. ALL OTHER ORIGINAL IMPLANTED DEVICES REMAINED IN THE BONE, AND THE BONE WAS COMPLETELY REMOVED FROM THE PATIENT¿S BODY. NO OTHER ARTHREX PARTS WERE IMPLANTED DURING THE REVISION SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED 07/29/2018: THE REP CONFIRMED THAT THE ORIGINAL SURGERY AND REVISION SURGERY TOOK PLACE AT THE SAME FACILITY. THE PATIENT WAS AN OLDER FEMALE. THE EXACT AGE OF THE PATIENT IS UNKNOWN. THE REP CONFIRMED THAT THE FOLLOWING ARTHREX PARTS WERE IMPLANTED IN THE ORIGINAL SURGERY ON (B)(6) 2018, AND ALL WERE EXPLANTED DURING THE REVISION SURGERY ON (B)(6) 2018. THE SURGEON ELECTED TO DO A PROXIMAL ROW CARPECTOMY AND THUS ALL IMPLANTS WERE THEN EXPLANTED IN THE PROCESS. AR-1530PS: LOT#: 858862 / QUANTITY: 1, AR-8978P: LOT#: F192202 / QUANTITY: 2. THE REP CONFIRMED ONE AR-8978P (LOT: F192202) WAS EXPLANTED BEFORE REMOVAL OF THE BONES DUE TO IT NO LONGER BEING IN BONE AND FLOATING IN THE JOINT. THE SECOND AR-8978P (LOT: F192202) AND AR-1530PS (LOT: 858862) WERE STILL IN THE BONE WHEN THE BONES WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630124 DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ARTHREX, INC. DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET F192202 00888867193925

    Patients

    Seq Age Sex Outcome Treatment
    1 Other