BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO PERFORATOR CHUCK

    MDR report key: 858646 · Received September 30, 2006

    Report

    Report Number
    1811755-2006-00044
    Event Type
    Malfunction
    Date Received
    September 30, 2006
    Date of Event
    August 16, 2006
    Report Date
    September 8, 2006
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    H6. DEVICE WAS NOT RETURNED FOR EVALUATION. STRYKER PERFORATOR CHUCK IS CLASSIFIED AS HBE UNDER REGULATION 882.4310 POWERED, SIMPLE CRANIAL DRILLS, BURS, TREPHINES AND THEIR ACCESSORIES. THIS REGULATION STATES "THE INSTRUMENTS ARE USED WITH A POWER SOURCE, BUT DO NOT HAVE A CLUTCH MECHANISM TO DISENGAGE THE TIP AFTER PENETRATING THE SKULL." THE BIT USED WITH OUR DEVICE FOR THIS PROCEDURE IS CLASSIFIED AS HBF UNDER REGULATION 882.4305, WHICH STATES "THE INSTRUMENTS EMPLOY A CLUTCH MECHANISM TO DISENGAGE THE TIP OF THE INSTRUMENTS AFTER PENETRATING THE SKULL TO PREVENT PLUNGING OF THE TIP INTO THE BRAIN."

    Description of Event or Problem · 1

    DURING SURGERY, AN ACRA-CUT PERFORATOR BIT BEING USED IN OUR PERFORATOR CHUCK PLUNGED. THE SURGEON WAS ABLE TO PREVENT THE BIT FROM PENETRATING THE DURA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAESTRO PERFORATOR CHUCK POWERED, SIMPLE CRANIAL DRILLS HBB STRYKER INSTRUMENTS KALAMAZOO * *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR