BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6MM DRILL BIT

    MDR report key: 4190104 · Received October 21, 2014

    Report

    Report Number
    1526439-2014-12014
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 24, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HTW
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE 6MM DRILL BIT REVEALED THAT THE FRACTURE WAS LOCATED AT THE DRILL BIT¿S WORKING END. THE SECOND HALF OF THE DRILL BIT WAS NOT PROVIDED FOR THIS ANALYSIS. OPTICAL IMAGES OF THE FRACTURE SURFACE REVEAL PLASTIC DEFORMATION AND TORSIONAL SHEAR MARKINGS FOLLOWING A CIRCULAR PATTERN AROUND THE CANNULATION. THE IMAGES SHOW EVIDENCE OF A QUASI-STATIC TORSIONAL SHEAR THAT IS EXTENDED AROUND THE CENTER OF THE SHAFT. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCIES. PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A 12-MONTH REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE DEVICE FOUND NO OTHER COMPLAINTS OF THIS NATURE. THE ROOT CAUSE OF THE 6MM DRILL BIT BECOMING BROKEN CANNOT POSITIVELY BE DETERMINED. HOWEVER, THE FRACTURE ANALYSIS REPORT SHOWS EVIDENCE OF A QUASI-STATIC TORSIONAL SHEAR THAT IS EXTENDED AROUND THE CENTER OF THE SHAFT. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS HAVE BEEN OBSERVED, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN NAVIGATING THE FACET JOINT AND PEDICLE WITH THE 6MM DRILL BIT WHICH WAS OVER THE WIRE, THE DRILL BIT BROKE ABOUT 5-10MM DOWN THE SHAFT OF THE DRILL ITSELF LEAVING THE DISTAL PIECE STUCK IN THE PATIENT. AS A RESULT OF THE DIFFICULTY, THE PROCEDURE WAS EXTENDED BY TWENTY MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668577 6MM DRILL BIT BIT, DRILL HTW DEPUY SYNTHES SPINE PU55496

    Patients

    Seq Age Sex Outcome Treatment
    1