BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSYNC EVANS WEDGE, 18 X 18 X 6.5 MM

    MDR report key: 10958399 · Received December 7, 2020

    Report

    Report Number
    1220246-2020-02391
    Event Type
    Injury
    Date Received
    December 7, 2020
    Date of Event
    November 5, 2020
    Report Date
    December 7, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    PLF
    UDI-DI
    00888867202764
    PMA / PMN Number
    K151256
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 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 A PATIENT HAD AN INITIAL DISTAL EXTREMITY EVANS OSTEOTOMY SURGERY (B)(6) 2019 USING AN AR-8942-1809 (LOT 4266), BIOSYNC EVANS WEDGE 18 X 18 X 6.5. THE PATIENT WAS COMPLAINING ABOUT NEW FOOT PAIN WITH NO REPORT OF ANY TRAUMATIC EVENT. PATIENT WOKE UP ONE MORNING WITH A GOOD DEAL OF PAIN IN THEIR PREVIOUSLY OPERATED ON FOOT. (B)(6) 2020 THE PATIENT UNDERWENT A SECOND SURGERY. AFTER DISSECTION IT WAS NOTICE INSTANTLY THAT THE BIOSYNC EVAN WEDGE WAS BROKEN. IT WAS FRAGMENTED INTO FOUR SEPARATE PIECES, ONLY BEING HELD IN PLACE BY IT'S SCREWS. SURGEON RELAYED TO THE SALES REP THAT HE WAS SHOCKED THAT THIS ISSUE OCCURRED, ADDING THAT HE HAD NEVER SEEN ONE BREAK BEFORE. THE DEVICE WILL NOT BE RETURNED AS THE FACILITY KEPT IT FOR PATHOLOGY. ADDITIONAL INFORMATION OBTAINED 11/17/20: TO REMOVED THE BIOSYNC EVANS WEDGE THE TWO ORIGINAL IMPLANTED SCREWS ALSO HAD TO BE EXPLANTED. THE TWO SCREWS WERE AS FOLLOWS: LOW PROFILE SCREW, 2.4 X 20MM, CORTEX (AR-8724-20, LOT # 193349), LOW PROFILE SCREW, 2.4 X 24MM, CORTEX (AR-8724-24, LOT #199124). THE REVISION PROCEDURE WAS COMPLETED WITH A LIFENET ILIAC CREST WEDGE AND THE FOLLOWING ARTHREX PRODUCTS. AR-8952XM, X-PLATE, MEDIUM 3.0MM, LOT 5261727, AR-8933V-22, 3.0 X 22MM VAL SCREW, LOT 4455693, AR-8933V-24, 3.0 X 24MM VAL SCREW, LOT 031838, AR-8933V-26. 3.0 X 26MM VAL SCREW, LOT 031834.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1424640 BIOSYNC EVANS WEDGE, 18 X 18 X 6.5 MM BONE WEDGE PLF ARTHREX, INC. BIOSYNC EVANS WEDGE, 18 X 18 X 6.5 MM 4266 00888867202764

    Patients

    Seq Age Sex Outcome Treatment
    1 Other