BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT DRIVE DRILL BIT

    MDR report key: 4972904 · Received August 5, 2015

    Report

    Report Number
    0001811755-2015-02843
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 8, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GFG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RADIOLUCENT DRILL BIT SUBJECT TO THIS EVENT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE CONCOMITANT HANDPIECE DRILL (4100355000) WAS RETURNED FOR EVALUATION. DEVICE DISCARDED BY CUSTOMER.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT YET RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A T2 TIBIAL NAIL SURGERY, THE OPERATION OF RADIOLUCENT ATTACHMENT HAD STOPPED, THE SURGEON USED ANOTHER ATTACHMENT TO SUCCESSFULLY COMPLETE THE SURGERY. IT WAS ALSO REPORTED THAT AFTER SURGERY, IT WAS NOTED THE RADIOLUCENT DRILL BIT WAS BROKEN WHEN REMOVING IT FROM THE FIRST ATTACHMENT THAT HAD STOPPED. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A T2 TIBIAL NAIL SURGERY, THE OPERATION OF RADIOLUCENT ATTACHMENT HAD STOPPED, THE SURGEON USED ANOTHER ATTACHMENT TO SUCCESSFULLY COMPLETE THE SURGERY. IT WAS ALSO REPORTED THAT AFTER SURGERY, IT WAS NOTED THE RADIOLUCENT DRILL BIT WAS BROKEN WHEN REMOVING IT FROM THE FIRST ATTACHMENT THAT HAD STOPPED. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513904 RADIOLUCENT DRIVE DRILL BIT BIT, SURGICAL GFG STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR