BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILOK RESORBABLE INTERFERENCE SCREW TAPERED

    MDR report key: 2852937 · Received November 27, 2012

    Report

    Report Number
    3006524618-2012-00924
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 29, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    HWC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FRONT ACL CRAFT PROCEDURE USING A BILOK SCREW, THE HEAD OF THE SCREW BROKE OFF INSIDE THE PATIENT. THE SURGEON WAS UNABLE TO RETRIEVE THE BROKEN PIECE AND IT WAS ABANDONED IN THE PATIENT. AN ADDITIONAL ARTICULAR FIXATION WAS PERFORMED TO COMPLETE THE PROCEDURE. THERE WERE NO SIGNIFICANT DELAYS OR FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BILOK RESORBABLE INTERFERENCE SCREW TAPERED ORTHOPEDIC MANUAL SURGICAL INTRUMENT HWC ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other