BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATOR #1

    MDR report key: 9949891 · Received April 10, 2020

    Report

    Report Number
    0001032347-2020-00216
    Event Type
    Malfunction
    Date Received
    April 10, 2020
    Date of Event
    March 30, 2020
    Report Date
    August 12, 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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT CANNOT BE VERIFIED. FUNCTIONAL TESTING AND INSPECTIONS COULD NOT BE PERFORMED DUE TO THE PARTS NOT BEING RETURNED. THE DHR WAS NOT REVIEWED DUE TO THE LOT NUMBERS BEING UNKNOWN. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THE PART/LOT COMPLAINT REVIEW COULD NOT BE PERFORMED DUE TO THE LOT NUMBERS BEING UNKNOWN. THE MOST LIKELY UNDERLYING 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2020-00215. MEDICAL PRODUCTS: ELEVATOR #77R, PART# 09-0313, LOT# NI, ELEVATOR #1, PART# 09-0259, LOT# NI.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSTRUMENT FRACTURED DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH A BACK-UP INSTRUMENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413515 ELEVATOR #1 ELEVATOR, SURGICAL, DENTAL EMJ BIOMET MICROFIXATION N/A UNK 00841036028206

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10 NARRATIVE.