BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATOR #301

    MDR report key: 5694743 · Received June 2, 2016

    Report

    Report Number
    0001032347-2016-00264
    Event Type
    Malfunction
    Date Received
    June 2, 2016
    Report Date
    April 25, 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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. THIS IS REPORT 2 OF 5 FOR THE SAME EVENT. REPORTS 1, 3-5 ARE REPORTED ON MFR #:0001032347-2016-00263, 0001032347-2016-00265 THROUGH 0001032347-2016-00267.

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF THE DEVICE HISTORY RECORDS SHOW THAT THE LOT WAS RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. ACCORDING TO THE PRODUCT EVALUATION, THE COMPLAINT IS CONFIRMED AS THE TIP OF THE ELEVATOR IS SLIGHTLY BENT. THE MOST-LIKELY, UNDERLYING CAUSE OF THE COMPLAINT WAS DETERMINED TO BE EXCESSIVE FORCE. THE INSTRUCTIONS FOR USE STATES, "THE TIP OF THE INSTRUMENT IS EXTREMELY THIN AND DELICATE; CARE SHOULD BE TAKEN TO AVOID APPLYING SIGNIFICANT PRESSURE TO THE TIP." THE NON-CONFORMANCE DATABASE WAS REVIEWED IN THE PRODUCT EVALUATION AND NO NON-CONFORMANCES WERE FOUND FOR THIS LOT. THERE IS NO INDICATION OF MANUFACTURING DEFECTS. THIS IS REPORT 3 OF 6 FOR THE SAME EVENT. REPORTS 1, 2, AND 4 THROUGH 6 ARE REPORTED ON MFR # 0001032347-2016-00230-2, 0001032347-2016-00263-1, 0001032347-2016-00265-1 THROUGH 0001032347-2016-00267-1.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SIX ELEVATOR #301'S WERE BROKEN AND/OR BENT DURING DIFFERENT SURGERIES. THERE WAS NO DELAY IN ANY OF THE SURGERIES, ALL PARTS WERE RETRIEVED IN EACH CASE, AND THERE WAS NO INJURY TO THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350423 ELEVATOR #301 ELEVATOR EMJ BIOMET MICROFIXATION N/A 022615B15

    Patients

    Seq Age Sex Outcome Treatment
    1