BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)

    MDR report key: 5857288 · Received August 9, 2016

    Report

    Report Number
    0001032347-2016-00388
    Event Type
    Injury
    Date Received
    August 9, 2016
    Date of Event
    July 4, 2016
    Report Date
    July 11, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK081067
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. 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. REPORT TWO OF THREE FOR THE SAME EVENT, REFERENCE 1032347-2016-00387 AND 1032347-2016-00389.

    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. BASED ON THE PRODUCT RETURN, THE FOLLOWING WERE UPDATED: DEVICE AVAILABLE FOR EVALUATION, DATE RECEIVED BY MFR, IF FOLLOW-UP, WHAT TYPE?, DEVICE EVALUATED BY MFR?, EVALUATION CODES, AND ADDITIONAL MFR NARRATIVE. THIS IS REPORT TWO OF THREE FOR THE SAME EVENT. REPORTS ONE AND THREE ARE REPORTED ON MFR #1032347-2016-00387 AND 1032347-2016-00389.

    Additional Manufacturer Narrative · 1

    THE PRODUCT THAT WAS RETURNED IS NOT THE EXPLANTED PRODUCT/ PRODUCT IN QUESTION. IT WAS CLARIFIED THAT THE EXPLANTED PRODUCT HAS BEEN QUARANTINED AND WHAT WAS RETURNED ARE THE REMAINING SCREWS FROM THE SAME LOT THAT WERE NOT USED AT ALL. A PRODUCT EVALUATION WILL BE CONDUCTED ON THE SCREWS THAT WERE RETURNED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PRODUCT EVALUATION. THIS IS REPORT TWO OF THREE FOR THE SAME EVENT. REPORTS ONE AND THREE ARE REPORTED ON MFR #1032347-2016-00387-2 AND 1032347-2016-00389-2.

    Additional Manufacturer Narrative · 1

    FIVE 41-2308 SCREWS WERE RETURNED AND VISUALLY EVALUATED UNDER A DIGITAL MICROSCOPE AND IT WAS SEEN THAT THE THREADS ARE FULLY IN TACT AND ON FOUR OF THE FIVE SCREWS THERE IS NO DAMAGE TO THE HEAD OF THE SCREWS, INDICATING THAT A BLADE WAS NEVER INSERTED INTO THE SCREW HEAD AND THERE IS DAMAGE TO THE CROSS DRIVE, INDICATING THAT A BLADE WAS INSERTED AND GOOD RETENTION OCCURRED. THE SCREWS WERE FUNCTIONALLY TESTED BY USING A 2.0 DRILL (PN: 72-2018) TO DRILL THE PILOT HOLE AND THEN INSERTING THE SCREWS INTO THE WHITE OAK WOOD BLOCK. THE SCREWS FULLY SEATED INTO THE WHITE OAK WOOD BLOCK WITH EASE. THE MOST LIKELY UNDERLYING CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED AS THE SCREWS FUNCTIONED AS INTENDED. SUPPLEMENTAL REPORT TWO OF THREE FOR THE SAME EVENT, REFERENCE 1032347-2016-00387-3 AND 1032347-2016-00389-3.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ORTHOGNATHIC SURGERY, SEVERAL SCREWS WERE UNABLE TO BE FIXATED. THE SURGEON STATED HE BELIEVES THE DRILLS MAY HAVE CREATED TOO LARGE OF A HOLE FOR THE SCREWS. THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE BY USING ANOTHER SYSTEM. A FORTY-FIVE MINUTE SURGICAL DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511269 FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) SCREW 2.3X8MM CROSS-DRIVE JEY BIOMET MICROFIXATION N/A 036330

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R