BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT DRIVE DRILL BIT

    MDR report key: 5026822 · Received August 25, 2015

    Report

    Report Number
    0001811755-2015-03097
    Event Type
    Malfunction
    Date Received
    August 25, 2015
    Date of Event
    July 30, 2015
    Report Date
    July 30, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GFG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE DISCARDED.

    Additional Manufacturer Narrative · 1

    THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A T2SCN SURGERY; WHILE DRILLING THE PROXIMAL SCREW HOLE, THE DRILL BIT BROKE. IT WAS ALSO REPORTED THAT THE BROKEN PIECE REMAINED IN THE PATIENT. IT WAS FURTHER REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A (B)(4) SURGERY; WHILE DRILLING THE PROXIMAL SCREW HOLE, THE DRILL BIT BROKE. IT WAS ALSO REPORTED THAT THE BROKEN PIECE REMAINED IN THE PATIENT. IT WAS FURTHER REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562535 RADIOLUCENT DRIVE DRILL BIT BIT, SURGICAL GFG STRYKER INSTRUMENTS-KALAMAZOO 15104017

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR