BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRILL, 1.5X105MM, 22MM STOP, J NOTC

    MDR report key: 1200224 · Received October 2, 2008

    Report

    Report Number
    1032347-2008-00065
    Event Type
    Other
    Date Received
    October 2, 2008
    Date of Event
    September 20, 2008
    Report Date
    September 23, 2008
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HTW
    PMA / PMN Number
    K062842
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT INDICATED THE DRILL WAS REVIVED PRIOR TO USING. THE WARNINGS IN THE PACKAGE INSERT STATE THIS ACTIVITY SHOULD NOT OCCUR AND THAT INTRAOPERATIVE FRACTURE OF BREAKING OF TWIST DRILLS HAS BEEN REPORTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    WHILE DRILLING IN THE MANDIBLE, DRILL BROKE. SURGERY WAS DELAYED ABOUT 2 HOURS, WHILE THE DOCTOR REMOVED THE BROKEN PIECE OF THE DRILL FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL, 1.5X105MM, 22MM STOP, J NOTC BONE DRILL HTW BIOMET MICROFIXATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization