BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0 MM/ 2.4 MM SYSTEM 45 MM, LONG, DEPTH GAGE

    MDR report key: 8233115 · Received January 10, 2019

    Report

    Report Number
    0001032347-2019-00021
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Report Date
    February 20, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EIL
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE PRODUCT IDENTITIES WERE CONFIRMED. THE 2.0 MM/ 2.4 MM SYSTEM 45 MM, LONG, DEPTH GAGE (PART# 01-9125, LOT #: 612980, SERIAL# 413328) WAS VISUALLY EVALUATED. THE GAGE SHOWED SIGNS OF USE WITH SOME SCRATCHES AT THE BASE OF THE HANDLE AND A BENT GAGE GUIDE. THE DEPTH GAGE CANNOT PROVIDE AN ACCURATE DEPTH MEASUREMENT WITH A BENT GUIDE, THEREFORE THE COMPLAINT IS CONFIRMED. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT IS EXCESSIVE FORCE WAS APPLIED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. IN THE WARNINGS AND PRECAUTIONS SECTION OF THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT IT IS STATED, 'AVOID UNDUE STRESS OR STRAIN WHEN HANDLING OR CLEANING INSTRUMENTS.' THE DISCOLORATION IS MOST LIKELY DUE TO RESIDUAL FROM THE CLEANING PROCESS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2019-00022-1, 0001032347-2019-00022-1, 0001032347-2019-00024-1, AND AND 0001032347-2019-00067.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2019-00021 THROUGH 0001032347-2019-00024.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEPTH GAGE WAS BROKEN. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25806 2.0 MM/ 2.4 MM SYSTEM 45 MM, LONG, DEPTH GAGE DEPTH GAGE EIL BIOMET MICROFIXATION N/A 612980

    Patients

    Seq Age Sex Outcome Treatment
    1