BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATOR #301

    MDR report key: 5667491 · Received May 19, 2016

    Report

    Report Number
    0001032347-2016-00230
    Event Type
    Malfunction
    Date Received
    May 19, 2016
    Report Date
    April 25, 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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. BECAUSE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORDS COULD NOT BE PULLED AND 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

    THE PRODUCT WAS RETURNED FOR EVALUATION. 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 1 OF 6 FOR THE SAME EVENT. REPORTS 2 THROUGH 6 ARE REPORTED ON MFR # 0001032347-2016-00263-1 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
    321716 ELEVATOR #301 ELEVATOR EMJ BIOMET MICROFIXATION N/A 071712G12

    Patients

    Seq Age Sex Outcome Treatment
    1