BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATOR #301

    MDR report key: 5055970 · Received September 4, 2015

    Report

    Report Number
    0001032347-2015-00371
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Report Date
    August 13, 2015
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EMJ
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELEVATOR WAS VISUALLY EVALUATED AND A SMALL PORTION OF THE TIP WAS FOUND TO BE FRACTURED. THE BROKEN TIP FRAGMENT WAS NOT RETURNED. THE ELEVATOR SHOWS SIGNS OF NORMAL WEAR FROM TYPICAL USE. THERE WAS ALSO SEEN TO BE SOME FORM OF MEDICAL TAPE AND RESIDUE LEFT ON THE TIP, LIKELY FROM THE HOSPITAL. THE NON-CONFORMANCE DATABASE WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT OF PARTS. THE MOST LIKELY CAUSE OF THE COMPLAINT WAS OPERATION OF INSTRUMENT OUTSIDE OF THE INTENDED USE (EXCESSIVE FORCE), RESULTING IN FAILURE.

    Additional Manufacturer Narrative · 1

    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

    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.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INSTRUMENT THAT BROKE DURING A PROCEDURE. NO ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589341 ELEVATOR #301 ELEVATOR EMJ BIOMET MICROFIXATION N/A 011014A14

    Patients

    Seq Age Sex Outcome Treatment
    1