BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HTR*PMI TOUNG RIGHT FRONTAL PARIETAL

    MDR report key: 9428464 · Received December 6, 2019

    Report

    Report Number
    0001032347-2019-00552
    Event Type
    Malfunction
    Date Received
    December 6, 2019
    Report Date
    April 24, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    KKY
    PMA / PMN Number
    K924935
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS CONFIRMED. THE HTR-PMI TOUNG RT FRT PAR (PART# PM622422, LOT# 930870) WAS RETURNED FOR RELABELING. THE HTR-PMMA CRANIAL DESIGN INPUT FORM SHOWS THE PATIENT'S LAST NAME SPELLED TOUNG, HOWEVER, THE DHR SHOWS AN HTR INSPECTION RECORD SHEET, ROUTER, LABEL, PATIENT MATCHED IMPLANT ORDER GENERATION FORM, AND CASE INFORMATION AND APPROVAL FORM WITH THE SPELLING TUONG. THE SALES ASSOCIATE CONFIRMED THE CORRECT SPELLING IS TOUNG. THE DHR FOR THIS PRODUCT WAS REVIEWED; NO ADDITIONAL NON-CONFORMANCES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS ASIDE FROM THE INCORRECT SPELLING ON THE LABEL. FOR PATIENT MATCHED HTR-PMI IMPLANTS (PMXXXXXX) AND THE PREVIOUS YEAR (FROM THE NOTIFICATION DATE) REGARDING MISLABELING ISSUES, THERE IS A CALCULATED COMPLAINT RATE IS(B)(4) WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE APPLICATION FMEA. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT IS HUMAN ERROR DURING THE DESIGN AND MANUFACTURING OF THE PRODUCT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THE FOLLOWING FIELDS WERE UPDATED: DATE OF THIS REPORT, DESCRIBE EVENT OR PROBLEM, EXPIRATION DATE, DEVICE AVAILABILITY, DATE RECEIVED BY MANUFACTURER, TYPE OF REPORT, FOLLOW UP TYPE, DEVICE EVALUATED BY MANUFACTURER, METHOD CODE, RESULTS CODE, CONCLUSIONS CODE, AND ADDITIONAL NARRATIVES/DATA.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S NAME WAS MISSPELLED ON THE IMPLANT LABEL. THE MALFUNCTION WAS DISCOVERED BEFORE SURGERY AND THE PLANNED SURGERY DATE WAS CANCELLED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229169 HTR*PMI TOUNG RIGHT FRONTAL PARIETAL CUSTOM MADE DEVICE KKY BIOMET MICROFIXATION N/A 930870

    Patients

    Seq Age Sex Outcome Treatment
    1