BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATOR #1

    MDR report key: 10784376 · Received November 4, 2020

    Report

    Report Number
    0001032347-2020-00554
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    October 19, 2020
    Report Date
    December 14, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EMJ
    UDI-DI
    00841036028206
    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 09-0259 LOT 071316F16. 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 INSTRUMENT BROKE. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250903 ELEVATOR #1 ELEVATOR, SURGICAL, DENTAL EMJ BIOMET MICROFIXATION N/A 071316F16 00841036028206

    Patients

    Seq Age Sex Outcome Treatment
    1