BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATOR #77 R

    MDR report key: 6084105 · Received November 7, 2016

    Report

    Report Number
    0001032347-2016-00646
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    October 12, 2016
    Report Date
    October 13, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EMJ
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF THE DEVICE HISTORY RECORDS SHOW THAT THE LOT WAS RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. 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

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION. THE PRODUCT IDENTITY WAS CONFIRMED IN THE EVALUATION. A VISUAL INSPECTION REVEALED MODERATE SIGNS OF WEAR INCLUDING MINOR SCRATCHES ALONG THE LENGTH OF THE INSTRUMENT, A PIECE OF PURPLE TAPE WRAPPED RIGHT ABOVE THE HANDLE, ALONG WITH A FRACTURED TIP; THEREFORE THE COMPLAINT IS CONFIRMED. THE MOST LIKELY UNDERLYING CAUSE WAS DETERMINED TO BE EXCESSIVE FORCE. ACCORDING TO THE EVALUATION, THERE ARE NO INDICATIONS OF A MANUFACTURING DEFECT. BASED ON THE PRODUCT EVALUATION, THE FOLLOWING WERE UPDATED: DATE RECEIVED BY MFR, IF FOLLOW-UP, WHAT TYPE?, DEVICE EVALUATED BY MFR?, EVALUATION CODES, AND ADDITIONAL MFR NARRATIVE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE TIP OF THE ELEVATOR BROKE DURING A PROCEDURE. IT IS REPORTED THAT THE SURGEON WAS ABLE TO PICK THE BROKEN TIP UP AND EXCHANGE IT FOR ANOTHER ELEVATOR TO COMPLETE THE REMOVAL OF THE TOOTH. IT IS REPORTED THAT THERE WAS A DELAY OF A FEW MINUTES TO THE PROCEDURE. IT IS REPORTED THAT THERE WAS NO FOREIGN BODY LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732066 ELEVATOR #77 R ELEVATOR EMJ BIOMET MICROFIXATION N/A 011415A15

    Patients

    Seq Age Sex Outcome Treatment
    1