BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT DRIVE DRILL BIT

    MDR report key: 3804247 · Received May 12, 2014

    Report

    Report Number
    0001811755-2014-01694
    Event Type
    Malfunction
    Date Received
    May 12, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 16, 2014
    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

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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE TIP OF THE DRILL BIT BROKE. IT WAS FURTHER REPORTED THAT THE SURGEON REMOVED THE TIP OF THE BROKEN DRILL BIT FROM THE PATIENT¿S BONE. THERE WERE NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE TIP OF THE DRILL BIT BROKE. IT WAS FURTHER REPORTED THAT THE SURGEON REMOVED THE TIP OF THE BROKEN DRILL BIT FROM THE PATIENT¿S BONE. THERE WERE NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284676 RADIOLUCENT DRIVE DRILL BIT BIT, SURGICAL GFG STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1