BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATOR #1

    MDR report key: 9848722 · Received March 18, 2020

    Report

    Report Number
    0001032347-2020-00173
    Event Type
    Malfunction
    Date Received
    March 18, 2020
    Report Date
    July 22, 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
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS CONFIRMED. THE ELEVATOR #1 (P/N: 09-0259, LOT# 011413A13, QTY 1) WAS RETURNED FOR INVESTIGATION. UPON REVIEW OF THE ELEVATOR, IT WAS NOTED THAT IT HAD A FRACTURE AT THE TIP. THE NON-CONFORMANCE DATABASE WAS REVIEWED FOR THIS PART/LOT# COMBINATION AND THERE WERE NO NON-CONFORMANCES FOUND RELATED TO THIS ISSUE. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. A COMPLAINT REVIEW WAS PERFORMED FOR THIS PART AND LOT NUMBER COMBINATION AND THERE IS AN OCCURRENCE RATE OF 0.22%. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT IS THAT THE ELEVATOR TIP EXPERIENCED FORCE IN EXCESS OF WHAT IT 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). IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE RETURNED FOR EVALUATION. 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 FRACTURED. ATTEMPTS HAVE BEEN MADE BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313843 ELEVATOR #1 ELEVATOR, SURGICAL, DENTAL EMJ BIOMET MICROFIXATION N/A 011413A13 00841036028206

    Patients

    Seq Age Sex Outcome Treatment
    1