BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN DISPOSABLE PERFORATOR

    MDR report key: 1180822 · Received September 23, 2008

    Report

    Report Number
    1226348-2008-00243
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    July 30, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HBF
    PMA / PMN Number
    K791101
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HISTORICALLY FOR COMPLAINTS OF THIS NATURE, THE RETURNED PERFORATORS HAVE BEEN VISUALLY INSPECTED AS RECEIVED, DISASSEMBLED AND CLEANED, AND THEN VISUALLY AND DIMENSIONALLY INSPECTED. NO DISCREPANCIES HAVE BEEN FOUND. THE PERFORATORS HAVE BEEN REASSEMBLED AND WERE FUNCTIONALLY TESTED FOR CUTTING AND DRILLING. THEY'VE BEEN FOUND TO MEET SPECIFICATION REQUIREMENTS. THE REPORTED CONDITION COULD NOT BE DUPLICATED. REVIEWS OF THE DEVICE HISTORY RECORDS HAVE FOUND NO DISCREPANCIES. THE COMPLAINTS HAVE BEEN CONFIRMED. A FOLLOW UP REPORT WILL BE FILED IF THE INVESTIGATION OF THIS DEVICE REVEALS A RESULT DIFFERENT FROM THAT WHICH IS STATED ABOVE OR IF ANY FURTHER INFORMATION REGARDING THE CAUSE OR MODE OF FAILURE IS MADE AVAILABLE. OTHERWISE, THE COMPLAINT IS CONSIDERED TO BE CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE CUSTOMER COMPLAINED THAT THE TREPAN DID NOT STOP IN TIME. THEY USED IT IN THE AREA FRONTAL AT THE LATERAL ORBIT BORDER. IT WAS ALSO NOTED THAT THE SURGEON TOOK INTO ACCOUNT THAT DUE TO THE STRUCTURE OF THE BONE IN THIS AREA THE PERFORATOR CAN NICK THE DURA. AFTER THE FIRST HOLE IT WAS IMPOSSIBLE TO MAKE FURTHER HOLES BECAUSE TREPAN WAS FIDGETY AND NONCIRCULAR. WHEN THE SURGEON RECOGNIZED THAT THE TREPAN WORKED NONCIRCULAR SHE USED A NEW ONE WITHOUT ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN DISPOSABLE PERFORATOR DRILLS, BURRS, TREPHINES & ACC. HBF CODMAN & SHURTLEFF, INC. NA CA921

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR