BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATOR #0

    MDR report key: 10784364 · Received November 4, 2020

    Report

    Report Number
    0001032347-2020-00552
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    October 19, 2020
    Report Date
    December 3, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS CONFIRMED. VISUAL EVALUATION SHOWED SIGNS OF USE AS THERE WAS MINOR SCRATCHING ON THE BODY OF THE ELEVATOR. FURTHER EVALUATION SHOWED THAT THE TIP HAD FRACTURED OFF. THE DHR WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS THE ONLY COMPLAINT IN REGARDS TO AN INSTRUMENT FRACTURE FOR 09-0258 LOT 100516I16. 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.

    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). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TIP OF THE INSTRUMENT FRACTURED DURING A PROCEDURE RESULTING IN A 30 MINUTE DELAY DUE TO AN X-RAY BEING TAKEN TO SEARCH FOR FRACTURED PIECES. NO FRACTURED PIECES OF THE INSTRUMENT WERE FOUND IN THE PATIENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250538 ELEVATOR #0 ELEVATOR, SURGICAL, DENTAL EMJ BIOMET MICROFIXATION N/A 100516I16 00841036028190

    Patients

    Seq Age Sex Outcome Treatment
    1