BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATOR #301

    MDR report key: 5419872 · Received February 9, 2016

    Report

    Report Number
    0001032347-2016-00053
    Event Type
    Malfunction
    Date Received
    February 9, 2016
    Report Date
    January 12, 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
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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

    THE DEVICE EVALUATION IS ANTICIPATED, A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE PRODUCT EVALUATION. REPORT ONE OF FOUR FOR THE SAME COMPLAINT; SEE ALSO 0001032347-2016-00053-1, 00125, 00126 AND 00127.

    Additional Manufacturer Narrative · 1

    ALL PARTS REPORTED FOR THIS EVENT WERE RETURNED AND EVALUATED FOR THE COMPLAINT THAT THE TIPS HAVE BROKEN. BASED ON THE PRODUCT EVALUATION, THE COMPLAINT FOR THIS PART AND LOT WAS UNCONFIRMED WITH A BENT TIP INSTEAD OF A BROKEN TIP. BASED ON THE PRODUCT EVALUATION, THE MOST-LIKELY UNDERLYING CAUSE OF THE BENT TIP WAS DETERMINED TO BE THE EXCESSIVE FORCE EXPERIENCED DURING USE OUTSIDE OF THE INTENDED USE. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS REPORT 1 OF 4 FOR THE SAME EVENT. REPORTS 2, 3, AND 4 ARE REPORTED ON MFR #0001032347-2016-00125-1, 0001032347-2016-00126-1, AND 0001032347-2016-00127-1.

    Description of Event or Problem · 1

    THE FACILITY REPORTED FOUR (4) 301 ELEVATORS BROKE AT THE TIP DURING FOUR DIFFERENT PROCEDURES. THE DATES AND SPECIFIC CASE DETAILS WERE UNABLE TO BE PROVIDED, HOWEVER IT WAS CONFIRMED THAT ALL PARTS OF THE INSTRUMENTS WERE RETRIEVED AND NO ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78082 ELEVATOR #301 ELEVATOR EMJ BIOMET MICROFIXATION N/A 061608F08

    Patients

    Seq Age Sex Outcome Treatment
    1