BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM LOCKING DRILL GUIDE 4MM X 32MM

    MDR report key: 6114634 · Received November 18, 2016

    Report

    Report Number
    1017294-2016-00123
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    October 22, 2016
    Report Date
    October 24, 2016
    Manufacturer
    CONMED CORPORATION
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEGAL MANUFACTURER ACUMED, LLC HAS THE COMPLAINT INVESTIGATION RESPONSIBILITY AND NOTIFICATION HAS BEEN SENT TO THE MANUFACTURER. A FOLLOW-UP AND FINAL REPORT WILL BE FILED BY ACUMED, LLC WITH THE EVALUATION RESULTS AND/OR INVESTIGATION FINDINGS. DEVICE HASN'T BEEN RETURNED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING USE OF THE 2.0MM LOCKING DRILL GUIDE 4MM-32MM IN AN ACUMED TRAUMA PROCEDURE, THE DRILL GUIDE TIP BROKE OFF. AS REPORTED, THE BREAKAGE OCCURRED DURING DRILLING OF THE 2MM DISTAL HOLES. THE BROKEN PORTION WAS SAFELY RETRIEVED WITH VERY LITTLE EFFECT ON SURGERY TIME. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO PATIENT INJURY AND ONLY 2-MINUTES DELAY. THIS REPORT IS FILED ON THE BASIS OF POTENTIAL FOR PATIENT INJURY WITH RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764748 2.0MM LOCKING DRILL GUIDE 4MM X 32MM GUIDE, SURGICAL, INSTRUMENT FZX CONMED CORPORATION 299205

    Patients

    Seq Age Sex Outcome Treatment
    1