BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VILEX CANNULATED DRILL BIT

    MDR report key: 4232359 · Received August 1, 2014

    Report

    Report Number
    1051526-2014-00006
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 31, 2014
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2014: RECEIVED CALL FROM ACCOUNT MANAGER THAT A STAPLE DRILL LODGED INTO THE DRILL GUIDE AND BROKE. ACCOUNT MANAGER STATED HE WOULD RETURN THE PRODUCTS. JULY 22, 2014: BROKEN DRILL AND DRILL GUIDE WERE RECEIVED FROM THE ACCOUNT MANAGER. JULY 25, 2014: VILEX'S QUALITY DEPARTMENT EVALUATED THE BROKEN DRILL AND THE DRILL GUIDE. DURING THE EVALUATION, IT WAS NOTICED THAT A PIECE OF THE DRILL WAS CEASED IN THE DRILL GUIDE. THE TIP OF THE DRILL HAD BEEN MANGLED. VILEX'S QC DEPARTMENT STATES THAT DRILL BIT SHOULD BE POINTED FROM THE TIP TO THE START OF THE FLUTE. THE BIT IN QUESTION WAS NO LONGER POINTED, WHICH MAY HAVE BEEN FROM DAMAGE THAT OCCURRED WITH INSERTING THE DRILL. THE CAUSE OF THIS DAMAGE COULD BE FROM IMPROPER CHUCKING OF THE DRILL OR FROM INSERTING THE DRILL AT AN IMPROPER ANGLE; THEREFORE, CAUSING HEAT TO BUILD UP AND CAUSING THE DRILL TO CEASE IN THE DRILL GUIDE. A REVIEW OF COMPLAINT RECORDS REVEALED THAT NO OTHER COMPLAINTS HAVE BEEN FILED AGAINST THIS PRODUCT. IF MORE INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DRILL BECAME LODGED IN DRILL GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450497 VILEX CANNULATED DRILL BIT 2.0X1.8MM STAPLE DRILL BIT HTW DA2018 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1