BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTECH, INC.

    MDR report key: 10774285 · Received November 2, 2020

    Report

    Report Number
    1038671-2020-00594
    Event Type
    Injury
    Date Received
    November 2, 2020
    Date of Event
    September 30, 2020
    Report Date
    November 13, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    LXH
    UDI-DI
    10885862010667
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE EVALUATION OF THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF APPLYING A BENDING MOMENT TO THE DRILL BIT WHILE DRILLING, WHICH LED TO ULTIMATE FRACTURE OF THE DEVICE. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION AND IMAGES WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    (H3) PENDING EVALUATION. NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S).

    Description of Event or Problem · 1

    AS REPORTED, DURING A PROCEDURE ON THIS (B)(6), THE DRILL BIT BROKE WHEN DRILLING THE LEFT ACETABULAR SCREW. THERE WERE NO X-RAYS TAKEN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239879 EXACTECH, INC. 3.2MM DRILL BIT30MM 1PK LXH EXACTECH, INC. 153880006 10885862010667

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention