BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATOR #301

    MDR report key: 5003075 · Received August 14, 2015

    Report

    Report Number
    0001032347-2015-00343
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Report Date
    July 15, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE (1) ELEVATOR #301 (PN 09-0257, LOT# A14, MANUFACTURED 2014) WAS RETURNED WITHOUT ORIGINAL PACKAGING FOR A BROKEN TIP. 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 SHOW SIGNS OF NORMAL WEAR FROM TYPICAL USE. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND THERE ARE NO MANUFACTURING ISSUES RELATED TO THIS LOT OF PARTS. THE MOST LIKELY CAUSE OF THE COMPLAINT WAS OPERATION OF INSTRUMENTS OUTSIDE OF THE INTENDED USE, RESULTING IN FAILURE. (B)(4)

    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 SUBMITTED WHEN THE DEVICE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE ELEVATOR BROKE DURING USE. NO ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539941 ELEVATOR #301 ELEVATOR EMJ BIOMET MICROFIXATION N/A 011014A14

    Patients

    Seq Age Sex Outcome Treatment
    1