BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5 MM LACTOSORB ADJUSTABLE SELF-DRILLING TAP

    MDR report key: 6144611 · Received December 5, 2016

    Report

    Report Number
    0001032347-2016-00729
    Event Type
    Injury
    Date Received
    December 5, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 9, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWX
    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

    THE PRODUCT WAS RETURNED FOR EVALUATION. THE PRODUCT IDENTITY HAS BEEN CONFIRMED IN THE EVALUATION. THE TAP WAS VISUALLY INSPECTED AND WAS FOUND TO BE FRACTURED THROUGH THE TIP; THEREFORE, THE COMPLAINT WAS CONFIRMED. THE TAP WAS OBSERVED UNDER A DIGITAL MICROSCOPE AND IT WAS DISCOVERED THAT THE TAP IS NOT FRACTURED THROUGH THE MINOR DIAMETER. THIS IS CONSISTENT WITH OTHER FRACTURES SEEN WHEN OFF AXIS FORCE IS APPLIED DURING TAPPING/DRILLING. THE TAP CANNOT BE FUNCTIONALLY TESTED AS IT IS FRACTURED. THE MOST LIKELY UNDERLYING CAUSE OF THIS COMPLAINT WAS DETERMINED TO BE DUE TO AN OFF AXIS FORCE BEING APPLIED TO THE TAP DURING USE. THE DEVICE HISTORY RECORDS WERE REVIEWED DURING THE EVALUATION AND NO NON-CONFORMANCES WERE FOUND. ACCORDING TO THE EVALUATION, THERE ARE NO INDICATIONS OF ANY MANUFACTURING DEFECTS.

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT IS REPORTED THAT DURING AN OPEN REDUCTION OF A CHEEKBONE FRACTURE, AFTER DRILLING AND WHILE TAPPING, THE TIP OF THE TAP BROKE. IT IS REPORTED THE BONE WAS SCRAPED IN ORDER TO REMOVE THE REMAINING PARTS OF THE TAP WITH FORCEPS. TO COMPLETE THE SURGERY, AN ITEM OF THE SAME PART NUMBER WAS USED. IT IS REPORTED THE SURGERY WAS COMPLETED WITH LESS THAN THIRTY MINUTES DELAY. IT IS REPORTED THAT THE DEVICE UNDERWENT 100% FULL INCOMING INSPECTION PRIOR TO THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796457 1.5 MM LACTOSORB ADJUSTABLE SELF-DRILLING TAP LACTOSORB TAP HWX BIOMET MICROFIXATION N/A 978400

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention