BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET MICROFIXATION FACIAL PLATING SYSTEM

    MDR report key: 6700709 · Received July 11, 2017

    Report

    Report Number
    0001032347-2017-00543
    Event Type
    Malfunction
    Date Received
    July 11, 2017
    Date of Event
    June 12, 2017
    Report Date
    December 11, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K142823
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DRIVER WAS EVALUATED FOR THE COMPLAINT THAT THE DRIVER WAS NOT FUNCTIONING AS INTENDED. THE INSTRUMENT WAS VISUALLY EVALUATED AND FOUND TO BE IN POOR OVERALL CONDITION. THERE WERE SCRATCHES AND NORMAL SIGNS OF WEAR ON THE INSTRUMENT; SIGNIFICANT DISCOLORATION WAS OBSERVED. UPON EVALUATION IT WAS FOUND THAT THERE IS NOT SMOOTH ROTATION WHILE TURNING THE KNOB; THEREFORE, THE COMPLAINT IS CONFIRMED. THERE WERE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS DRIVER WAS MANUFACTURED BEFORE THE IMPLEMENTATION DATE OF THE DESIGN CHANGE AND THEREFORE IS SUSCEPTIBLE TO OVER TORQUEING BY THE SURGEON. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT ISSUE IS EXCESSIVE FORCE.

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS SUBMITTED TO CORRECT THE DEVICE PRODUCT CODE AND 510(K) NUMBER. THE FOLLOWING SECTIONS WERE CORRECTED: DEVICE PRODUCT CODE: JEY CORRECTED TO HRS. PMA/510(K) NUMBER: K121589 CORRECTED TO K142823.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THE LOT WAS RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. 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

    DATE OF THIS REPORT WAS CORRECTED TO REFLECT (B)(6) 2017.

    Description of Event or Problem · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THOUGH THE DEVICE WAS INSPECTED PRIOR TO USE. DURING THE PLATING OF A POSTERIOR RIB FRACTURE THE DRIVER FAILED TO TURN THE BLADE TO DRIVE THE SCREW INTO THE PLATE AND MADE A "CLICKING" SOUND. THE EVENT RESULTED IN A FIVE MINUTE DELAY TO THE PROCEDURE. ANOTHER CONTRA ANGLE DRIVER WAS USED TO COMPLETE THE PROCEDURE. IT IS STATED THE SURGICAL TECHNIQUE FOR THE PRODUCT UTILIZED WAS USED AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480537 BIOMET MICROFIXATION FACIAL PLATING SYSTEM 90 DEGREE CONTRA ANGLE SCREWDRIVER HRS BIOMET MICROFIXATION N/A 999220

    Patients

    Seq Age Sex Outcome Treatment
    1