BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MICROFIXATION FACIAL PLATING SYSTEM

    MDR report key: 6540038 · Received May 3, 2017

    Report

    Report Number
    0001032347-2017-00344
    Event Type
    Injury
    Date Received
    May 3, 2017
    Date of Event
    March 31, 2017
    Report Date
    May 3, 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
    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 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.

    Additional Manufacturer Narrative · 1

    TWO SCREWS WERE RETURNED WITHOUT PACKAGING. THE SCREWS WERE VISUALLY EVALUATED AND FOUND TO BE IN GOOD CONDITION WITH NO SIGNIFICANT DAMAGE. THESE ARE EMERGENCY SCREWS, WHICH ARE NOT SELF DRILLING. THEY MUST BE INSERTED INTO A PRE-EXISTING HOLE (DRILLED OR FROM A STANDARD SCREW). A FUNCTIONAL TEST WAS PERFORMED TO TEST THE INSERTION BY INSERTING THE SCREW INTO AN EXISTING HOLE INTO A WHITE OAK BLOCK USING A 15-1194 BLADE. THE SCREW SUCCESSFULLY INSERTED FULLY INTO THE OAK BLOCK WITH NO ISSUES. THE BLADE AND DRILL USED BY THE CUSTOMER IS UNKNOWN. THE OVERALL COMPLAINT WAS UNCONFIRMED AS THE SCREW WAS ABLE TO BE INSERTED WITH NO ISSUES. THE MOST LIKELY CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED AS THE REPORTED EVENT COULD NOT BE SUBSTANTIATED. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS AND NO UPDATES TO THE RISK ASSESSMENTS NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, TWO SCREWS DID NOT INSERT INTO THE BONE WHILE USING A POWER DRILL AND MANUAL DRIVER. THE PROCEDURE WAS COMPLETED WITH OTHER SCREWS OF THE SAME ITEM NUMBER. THE SURGERY DELAY AND TYPE OF SURGERY ARE UNKNOWN.

    Description of Event or Problem · 1

    THE DISTRIBUTOR RESPONDED TO THE REQUESTS FOR ADDITIONAL INFORMATION; IT WAS REPORTED THE PATIENT DID NOT HAVE DENSE BONE AND THE DISTRIBUTOR IS UNAWARE OF ANY CONTRIBUTING FACTORS SUCH AS PATIENT ANATOMY OR PREVIOUS SURGERIES ETC... THE SCREW AND/OR A PORTION OF THE SCREW WAS INSERTED THEN REMOVED AND A NEW SCREW WAS INSERTED INTO THE SAME HOLE. THE DISTRIBUTOR STATED THE SURGICAL TECHNIQUE WAS NOT FOLLOWED, HOWEVER DID NOT PROVIDE AN EXPLANATION. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322023 BIOMET MICROFIXATION FACIAL PLATING SYSTEM SCREW, BONE, 1.5 X 5 MM HIGH TORQUE CROSS-DRIVE SCREW 5-PACK JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention