BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATOR #0

    MDR report key: 9428460 · Received December 6, 2019

    Report

    Report Number
    0001032347-2019-00539
    Event Type
    Malfunction
    Date Received
    December 6, 2019
    Report Date
    February 10, 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
    NJ, 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 AND THE TIP HAD FRACTURED OFF. THE DHR WAS REVIEWED AND THERE WERE NO NONCONFORMANCE'S FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS THE ONLY COMPLAINT REGARDING THE TIP FRACTURING FOR THIS PART 09-0258 LOT NUMBER 071318F18. 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). THE CUSTOMER HAS RETURNED THE DEVICE FOR EVALUATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INSTRUMENT FRACTURED DURING A DENTAL PROCEDURE. THE FRACTURED PIECE OF THE INSTRUMENT WAS REMOVED FROM THE PATIENT BY SUCTION AND THE PROCEDURE WAS COMPLETED WITH A BACK-UP INSTRUMENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1222871 ELEVATOR #0 ELEVATOR, SURGICAL, DENTAL EMJ BIOMET MICROFIXATION N/A 071318F18 00841036028190

    Patients

    Seq Age Sex Outcome Treatment
    1