BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRIVER, 33 MM, BILOK 2

    MDR report key: 1884146 · Received October 13, 2010

    Report

    Report Number
    2951580-2010-00093
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    September 3, 2010
    Report Date
    October 13, 2010
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL BE RETURNED FOR INVESTIGATION. ONCE THE DEVICE HAS BEEN RECEIVED, AN INVESTIGATION WILL BE PERFORMED AND PROVIDED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT UNDERWENT AN ACL RECONSTRUCTION OF THE KNEE USING AN ARTHROCARE DRIVER, 35 MM, BILOK 2. AFTER THE TIBIAL SCREW WAS PUT INTO PLACE IN THE PT, THE PHYSICIAN TRIED TO DISENGAGE THE DRIVER. WHEN THE PHYSICIAN DISENGAGED THE DRIVER, THE TIP BROKE OFF INTO THE SCREW AND REMAINS IN THE PT. THERE IS NO PLAN TO RE-OPERATE TO REMOVE THE PIECE AND NO ADVERSE CONSEQUENCE TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVER, 33 MM, BILOK 2 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHROCARE CORP. 26108

    Patients

    Seq Age Sex Outcome Treatment
    1 Other