BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM

    MDR report key: 2810126 · Received October 31, 2012

    Report

    Report Number
    1719045-2012-01120
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 3, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT # UM23497 REVEALED THE 6.0 MM/10.0 MM STEPPED DRILL BIT, CANNULATED LARGE QC/435 MM WAS MANUFACTURED BY (B)(4). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTIONS NOTED 6.0MM PORTION OF THE TIP IS BROKEN OFF. CHIPS AND DULL EDGES FOUND AT THE FRONT OF THE DRILL BIT. WEAR MARKS AT JACOBS CHUCK PORTION OF THE DRILL BIT. THE MANUFACTURING ENGINEER EVALUATED THE DEVICE AND THE REPORT INDICATES ORCHID UNIQUE MANUFACTURED THE 6.0MM/10.0MM STEP DRILL BIT, PART NUMBER 357.403, LOT NUMBER UM23497. THE INSTRUMENTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED FUNCTIONAL TESTING AT SYNTHES INCOMING INSPECTION. THE UNITS RETURNED FOR THE COMPLAINT MET MATERIAL REQUIREMENTS; THE HARDNESS WAS VERIFIED PER THE CERTIFICATE OF COMPLIANCE. THE PRODUCTS WERE INSPECTED FOR THE TIP FEATURES AND MET REQUIREMENTS. THE PRODUCT DEVELOPMENT ENGINEER EVALUATED THE DEVICE AND THE REPORT INDICATES THE DEVICE WAS SOLD IN (B)(4) 2003. THE 6.0/10.0MM STEPPED DRILL BIT IS USED TO CREATE A PATH FOR THE TFN HELICAL BLADE OR SCREW. THESE DRILL BITS DO NOT HAVE A SET DESIGNATED LIFE AS THEY CAN BE USED UNTIL THE EDGES APPEAR DULL OR DAMAGED, BUT SHOULD BE REPLACED ONCE ANY DAMAGE HAS BEEN NOTICED. THIS STEPPED DRILL BIT IS MADE FROM HEAT TREATED 440A, WHICH IS A COMMON MATERIAL USED IN THIS APPLICATION. THE DESIGN RISK ASSESSMENT WAS REVIEWED AND FOUND TO BE ADEQUATE FOR THE INTENDED USE.

    Description of Event or Problem · 1

    DURING A TFN PROCEDURE, THE STEPPED DRILL BIT TIP BROKE DURING THE DRILLING PROCESS. THE BROKEN DRILL BIT WAS BROKEN OFF INTO THE PATIENT, ALL FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS PROLONGED ABOUT 10-15 MINUTES BECAUSE OF THIS INCIDENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO FRAGMENTS REMAINING IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM STEPPED DRILL BITCANNULATED HTW SYNTHES MONUMENT UM23497

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR