BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.0MM CANNULATED DRILL BIT LARGE QC/190MM

    MDR report key: 2852057 · Received November 30, 2012

    Report

    Report Number
    1719045-2012-01211
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.

    Description of Event or Problem · 1

    DURING AN IMPLANT OF IM TIBIA NAIL PROCEDURE, SURGEON WAS REAMING WHEN THE DRILL BIT BROKE. THE DRILL BIT BROKE WHERE THE BIT FITS INTO THE DRILL. SURGEON DISCONNECTED THE DRILL BIT FROM THE DRILL USING THE KEY, AND THEN BACKED THE DRILL BIT OUT USING PLIERS. PROCEDURE WAS DELAYED BY APPROXIMATELY 2 TO 3 MINUTES. PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEM, NO HARM TO PATIENT. THE BROKEN DRILL BIT WAS DISCARDED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12.0MM CANNULATED DRILL BIT LARGE QC/190MM DRILL BIT HSB SYNTHES MONUMENT PE00526

    Patients

    Seq Age Sex Outcome Treatment
    1