BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MICROFIXATION FACIAL PLATING SYSTEM

    MDR report key: 6595587 · Received May 26, 2017

    Report

    Report Number
    0001032347-2017-00411
    Event Type
    Injury
    Date Received
    May 26, 2017
    Date of Event
    May 2, 2017
    Report Date
    November 30, 2017
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK121589
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. 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. THIS IS REPORT ONE OF TWO FOR THE SAME EVENT. REPORT TWO OF TWO IS REPORTED ON MFR #0001032347-2017-00412.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS IN PROGRESS, A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. THIS IS SUPPLEMENTAL REPORT ONE OF TWO FOR THE SAME EVENT; REFERENCE REPORT 0001032347-2017-00412-1.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT WAS CONFIRMED AS THE SCREWS WERE FOUND TO BE FRACTURED. FOUR (4) SCREWS FROM 1.5 X 4 MM HT SD X-DR SCREW (91-6104) AND ONE (1) SCREW FROM 1.5 X 5 MM HT SD X-DR SCREW (91-6105) WITH AN UNKNOWN MANUFACTURED DATE WERE RETURNED WITHOUT PACKAGING. THE SCREWS WERE VISUALLY EVALUATED AND FOUND TO BE FRACTURED. THE SLOTS IN THE HEAD OF THREE OF THE SCREWS SHOW SIGNS OF USE BUT NO SIGNIFICANT DAMAGE, INDICATING THE SCREWS RETAINED THE BLADE ALLOWING A HIGH TORQUE ON THE SCREWS TO BE ACHIEVED. THE REMAINING SCREW HEAD SLOTS SHOW MINOR DEFORMATION FROM NORMAL USE. ALL OF THE SCREWS HAVE BEEN FRACTURED AT THE FIRST MINOR DIAMETER FROM THE HEAD AND PERPENDICULAR TO THE LENGTH OF THE SCREW. THE FRACTURES ARE TYPICAL OF AN OVER TORQUED SCREW. THERE IS NO SIGN OF DISCOLORATION. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO EXCESSIVE FORCE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THIS IS SUPPLEMENTAL REPORT ONE OF TWO FOR THE SAME EVENT. SUPPLEMENTAL REPORT TWO OF TWO IS REPORTED ON MFR #0001032347-2017-00412-2.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING A CRANIOTOMY TO RESECTION A TUMOR, THE SCREWS WERE BROKEN AFTER THE SURGEON PERFORMED A FINAL TURN ON THEM. THREE OF FOUR OF THESE BROKEN SCREWS REMAIN IMPLANTED IN THE PATIENT'S SKULL. THIS EVENT DELAYED THE PROCEDURE BY TEN MINUTES. THE PROCEDURE WAS COMPLETED WITH SCREWS OF THE SAME SIZE. IT IS STATED THE SURGICAL TECHNIQUE WAS FOLLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374336 BIOMET MICROFIXATION FACIAL PLATING SYSTEM BONE SCREW, 1.5 X 4 MM HIGH TORQUE SELF-DRILLING CROSS-DRIVE SCREW JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention| S