BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE

    MDR report key: 6110069 · Received November 17, 2016

    Report

    Report Number
    0001032347-2016-00679
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 24, 2016
    Report Date
    October 25, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EIL
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PRODUCT CODE: EIL. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. THE PRODUCT WAS REQUESTED BUT WILL NOT BE RETURNED FOR AN EVALUATION. BECAUSE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORDS COULD NOT BE PULLED AND REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEPTH GAUGE BROKE INTO TWO PIECES DURING A PROCEDURE. IT IS REPORTED THAT THE BREAKAGE WAS DUE TO BEING WORN OUT AND OVER USED. IT IS REPORTED THE TWO PIECES DID NOT FALL INTO THE PATIENT. IT IS REPORTED THAT NO DELAY OVER THIRTY MINUTES OCCURRED AS A RESULT OF THIS EVENT. IT IS REPORTED THE PROCEDURE WAS COMPLETED WITH A SPARE DEPTH GAUGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762080 DEPTH GAUGE DEPTH GAUGE EIL BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1