BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATOR #301

    MDR report key: 6103284 · Received November 15, 2016

    Report

    Report Number
    0001032347-2016-00675
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Report Date
    October 27, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EMJ
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION REVEALED MODERATE SIGNS OF WEAR INCLUDING MINOR SCRATCHES ALONG THE LENGTH OF THE INSTRUMENT ALONG WITH A FRACTURED TIP. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO NON-CONFORMANCES WERE IDENTIFIED. THERE ARE NO INDICATIONS OF A MANUFACTURING DEFECT. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT WAS EXCESSIVE FORCE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE TIP OF THE #301 ELEVATOR BROKE WHILE REMOVING TOOTH #17. THE BROKEN TIP WAS RETRIEVED VIA SUCTION AND ANOTHER #301 ELEVATOR WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755020 ELEVATOR #301 ELEVATOR EMJ BIOMET MICROFIXATION N/A 011014A14

    Patients

    Seq Age Sex Outcome Treatment
    1