BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE TRAC THINFLAP 18.5MM BENT BURR PLATE

    MDR report key: 7519621 · Received May 16, 2018

    Report

    Report Number
    0001032347-2018-00283
    Event Type
    Malfunction
    Date Received
    May 16, 2018
    Report Date
    October 31, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    K972322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO PRODUCT WAS RETURNED AND NO FUNCTIONAL TESTS OR INSPECTIONS COULD BE PERFORMED. THE DISTRIBUTOR PROVIDED A SPREADSHEET WITH PICTURES; HOWEVER THE COMPLAINT COULD NOT BE VERIFIED DUE TO THE POOR QUALITY OF THE PICTURE. FOR THESE REASONS, THE COMPLAINT COULD NOT BE VERIFIED AND THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED TO DOCUMENT THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING INCOMING INSPECTION IT WAS IDENTIFIED THE PRODUCT IN THE PACKAGE IS A DIFFERENT PART FROM WHAT IS LISTED ON THE LABEL. THE PACKAGE CONTAINS CATALOG NUMBER 19-1020, BUT SHOULD CONTAIN CATALOG NUMBER 19-1020B. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361951 STERILE TRAC THINFLAP 18.5MM BENT BURR PLATE BONE PLATE JEY BIOMET MICROFIXATION N/A 319970

    Patients

    Seq Age Sex Outcome Treatment
    1