BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEAN SCISSORS SERRATED 17 CM 6-

    MDR report key: 6051859 · Received October 24, 2016

    Report

    Report Number
    0001032347-2016-00606
    Event Type
    Injury
    Date Received
    October 24, 2016
    Report Date
    September 27, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EGN
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE 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. THIS IS REPORT TWO OF FOUR FOR THE SAME EVENT. REPORTS ONE, THREE, AND FOUR ARE REPORTED ON MFR #0001032347-2016-00605. 0001032347-2016-00607. AND 0001032347-2016-00608.

    Additional Manufacturer Narrative · 1

    IT IS NOTED THAT THE CUSTOMER SHOWS A POSSIBLE LOT OF 051815E15 FOR THIS ITEM. HOWEVER, THE LOT NUMBER COULD NOT BE CONFIRMED AT THIS TIME. 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. THIS IS REPORT TWO OF FOUR FOR THE SAME EVENT. REPORTS ONE, THREE, AND FOUR ARE REPORTED ON MFR #0001032347-2016-00605. 0001032347-2016-00607. AND 0001032347-2016-00608.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION. THE PRODUCT IDENTITY WAS CONFIRMED AND THE LOT WAS IDENTIFIED IN THE EVALUATION. A VISUAL INSPECTION REVEALED MODERATE SIGNS OF WEAR INCLUDING MINOR SCRATCHES AND SPOTS OF DISCOLORATION. THIS PRODUCT WAS FOUND TO HAVE A BROKEN TIP; THEREFORE THE COMPLAINT IS CONFIRMED. THE MOST LIKELY UNDERLYING CAUSE WAS DETERMINED TO BE EXCESSIVE APPLIED FORCE. ACCORDING TO THE EVALUATION, THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS REPORT TWO OF NINE FOR THE SAME EVENT. REPORTS ONE, THREE, FOUR, AND FIVE THROUGH NINE ARE REPORTED ON MFR #0001032347-2016-00605-2, 0001032347-2016-00607-2, 0001032347-2016-00608-2, AND 0001032347-2016-00770 THROUGH 0001032347-2016-00774.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THIS INSTRUMENT'S TIP BROKE DURING A PROCEDURE. IT IS REPORTED THAT ALL PARTS WERE RETRIEVED AND THERE WAS NO FOREIGN BODY IN THE PATIENT. IT IS REPORTED THAT THE EVENT DID NOT LEAD TO A DELAY OF MORE THAN THIRTY MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703701 DEAN SCISSORS SERRATED 17 CM 6- SCISSORS EGN BIOMET MICROFIXATION N/A 060810E10

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention