BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATOR #0

    MDR report key: 9330484 · Received November 15, 2019

    Report

    Report Number
    0001032347-2019-00489
    Event Type
    Malfunction
    Date Received
    November 15, 2019
    Report Date
    January 28, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EMJ
    UDI-DI
    00841036028190
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS CONFIRMED. THE COMPLAINT WAS OPENED BECAUSE THE FACILITY REPORTED THE TIP OF THE INSTRUMENT BROKE OFF. THE ELEVATOR #0 (09-0258, LOT# 032613C13) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION SHOWED SIGNS OF USE AS THERE WAS MINOR SCRATCHING ON THE BODY OF THE ELEVATOR AND THE TIP HAD FRACTURED OFF. THE NON-CONFORMANCE DATABASE WAS REVIEWED FOR THIS PRODUCT, NO NON-CONFORMANCES WERE FOUND. COMPLAINT HISTORY FOR 09-0258, LOT# 032613C13 WAS REVIEWED AND THERE IS A COMPLAINT RATE OF 0.1%, WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE APPLICATION FMEA. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT IS THAT EXCESSIVE FORCE WAS USED, BEYOND WHAT THE INSTRUMENT WAS DESIGNED TO ENCOUNTER. 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: B4 DATE OF THIS REPORT B5 DESCRIBE EVENT OR PROBLEM D4 LOT NUMBER D10 DEVICE AVAILABILITY G4 DATE RECEIVED BY MANUFACTURER G7 TYPE OF REPORT H2 FOLLOW UP TYPE H3 DEVICE EVALUATED BY MANUFACTURER H6 METHOD CODE H6 RESULTS CODE H6 CONCLUSIONS CODE H10 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). 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 THAT AN INSTRUMENT FRACTURED DURING A DENTAL PROCEDURE. THE FRACTURED PIECE OF THE INSTRUMENT WAS REMOVED FROM THE PATIENT BY SUCTION AND THE PROCEDURE WAS COMPLETED WITH A BACK-UP INSTRUMENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122528 ELEVATOR #0 ELEVATOR, SURGICAL, DENTAL EMJ BIOMET MICROFIXATION N/A 032613C13 00841036028190

    Patients

    Seq Age Sex Outcome Treatment
    1