BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM SD LACTOSORB TAP

    MDR report key: 6064234 · Received October 28, 2016

    Report

    Report Number
    0001032347-2016-00624
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    September 8, 2016
    Report Date
    September 28, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HXW
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 1.5MM SCREW WAS NOT RETURNED FOR EVALUATION; THE SCREW PART AND LOT NUMBER REMAINS UNKNOWN. THE TWO TAPS WERE VISUALLY INSPECTED AND ALL OF THE THREADS REMAIN INTACT AND THE BODY OF EACH TAP SHOWS MINIMAL SIGNS OF USE. THE TAPS WERE FUNCTIONALLY TESTED BY USING IT TO TAP THREE HOLES INTO A WHITE OAK WOOD BLOCK AND THEN INSERTING A 1.5MM LACTOSORB SCREW (PN: 915-2326) INTO THE HOLE TO CHECK THE FIT. THE FUNCTIONAL TESTING REVEALED THAT THE TAPS FUNCTIONED AS INTENDED AND THE SCREW SEATED INTO THE HOLE. THE WARNINGS AND PRECAUTIONS IN THE PACKAGE INSERT STATE "THE LACTOSORB SELF-DRILLING DENSE BONE TAPS HAVE BEEN DESIGNED FOR SKELETALLY MATURE PATIENTS AND ARE NOT RECOMMENDED FOR SKELETALLY IMMATURE PATIENTS (I.E. SOFT BONE); USE IN SKELETALLY IMMATURE PATIENTS MAY RESULT IN POOR SCREW FIXATION." IF THE DENSE BONE TAP IS USED ON SOFT BONE IT CAN CAUSE THE THREADS TO BE TOO BIG INSIDE OF THE HOLE AND THE SCREW CAN PULL OUT INTRA-OPERATIVELY. THE MOST LIKELY UNDERLYING CAUSE OF THIS COMPLAINT IS DUE TO THE DENSE BONE TAP BEING USED ON SOFT BONE. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS.

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN OPEN REDUCTION PROCEDURE THE 1.5MM TAP DRILLED A LARGER HOLE THAN THE 1.5MM SCREW. THE SURGEON ATTEMPTED TO USE ANOTHER 1.5 TAP WITH THE SAME ISSUE. THE SURGEON HAD TO USE 2MM SCREW. THE PART AND LOT OF THE 1.5MM SCREW IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714798 1.5MM SD LACTOSORB TAP TAP, BONE HXW BIOMET MICROFIXATION N/A 780750

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention