BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATOR #301

    MDR report key: 12689706 · Received October 25, 2021

    Report

    Report Number
    0001032347-2021-00481
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    September 24, 2021
    Report Date
    December 21, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EMJ
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL VERIFICATION IDENTIFIED TIP IS FRACTURED IN THE WORKING END OF THE TIP. THERE ARE NO OTHER INDICATIONS THAT CAN BE OBSERVED THAT WOULD ASSIST IN THE EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    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 IS REPORTED THAT THE TIPS BROKE OFF DURING A PROCEDURE. THE FRACTURED TIP WAS RETRIEVED FROM 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
    1588342 ELEVATOR #301 ELEVATOR, SURGICAL, DENTAL EMJ BIOMET MICROFIXATION N/A J20

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown