BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT DRIVE DRILL BIT

    MDR report key: 4705350 · Received April 20, 2015

    Report

    Report Number
    0001811755-2015-01410
    Event Type
    Malfunction
    Date Received
    April 20, 2015
    Date of Event
    March 16, 2015
    Report Date
    March 24, 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

    THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A T2 SCN SURGERY; WHILE DRILLING THE PROXIMAL SCREW HOLE OF NAIL, THE DRILL BIT BROKE AT THE CUTTING END. IT WAS ALSO REPORTED THAT THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT'S BONE. IT WAS FURTHER REPORTED THAT ANOTHER DRILL BIT WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A T2 SCN SURGERY; WHILE DRILLING THE PROXIMAL SCREW HOLE OF NAIL, THE DRILL BIT BROKE. IT WAS ALSO REPORTED THAT THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT'S BONE. IT WAS FURTHER REPORTED THAT ANOTHER DRILL BIT WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261500 RADIOLUCENT DRIVE DRILL BIT BIT, SURGICAL GFG STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1