BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT DRIVE DRILL BIT

    MDR report key: 5349678 · Received January 7, 2016

    Report

    Report Number
    0001811755-2016-00017
    Event Type
    Malfunction
    Date Received
    January 7, 2016
    Date of Event
    December 11, 2015
    Report Date
    March 1, 2017
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GFG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS ONLY A PARTIAL PIECE OF THE DEVICE WAS RETURNED. THE QUALITY INVESTIGATION IS CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A T2 GTN SURGERY, THE RADIOLUCENT DRILL BIT BROKE AT THE BASE. 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 USING A BACKUP DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A T2 GTN SURGERY, THE RADIOLUCENT DRILL BIT BROKE AT THE BASE. 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 USING A BACKUP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9783 RADIOLUCENT DRIVE DRILL BIT BIT, SURGICAL GFG STRYKER INSTRUMENTS-KALAMAZOO 14076017

    Patients

    Seq Age Sex Outcome Treatment
    1