BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINICA DRILL BIT, 2.3, STERILE, ATO

    MDR report key: 2575681 · Received May 2, 2012

    Report

    Report Number
    2184052-2012-00020
    Event Type
    Malfunction
    Date Received
    May 2, 2012
    Date of Event
    April 2, 2012
    Report Date
    April 2, 2012
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFG RECORDS REVIEWED INDICATED NO DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED; THEREFORE, THE ROOT CAUSE IS UNABLE TO BE DETERMINED. THIS IS THE FINAL REPORT THAT WILL BE SUBMITTED ASSOCIATED WITH THIS INCIDENT AND DEVICE. NO ADD¿L ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY, THE DRILL TIP BROKE. LEVELS TREATED WERE C6-C7 DURING AN ACDF. THE SURGEON WAS DRILLING THE PILOT HOLE FOR THE SCREW AND THE DRILL PORTION OF THE DRILL BIT BROKE OFF IN THE VERTEBRAL BODY. THE DRILL BIT WAS NOT PREVIOUSLY USED AND THE SURGEON USED THE DRILL GUIDE. THE BROKEN PORTION COULD NOT BE REMOVED AND REMAINS IN THE PT. THE CASE WAS COMPLETED WITH NO DELAY TO THE CASE OR FURTHER PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRINICA DRILL BIT, 2.3, STERILE, ATO TRINICA DRILL BIT, 2.3, STERILE, ATO HTW ZIMMER SPINE, INC. 07.00660.003 60220888A

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR