BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET MICROFIXATION FACIAL PLATING SYSTEM

    MDR report key: 6486363 · Received April 12, 2017

    Report

    Report Number
    0001032347-2017-00268
    Event Type
    Malfunction
    Date Received
    April 12, 2017
    Date of Event
    February 1, 2017
    Report Date
    December 10, 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
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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

    THE PRODUCT IDENTITY WAS CONFIRMED IN THE EVALUATION. THE DRIVER WAS VISUALLY EVALUATED AND SHOWED SIGNS OF CONSIDERABLE USE. THE DRIVER WAS FUNCTIONALLY TESTED AND COULD NOT DRIVE A SCREW. DIS-ASSEMBLY REVEALED THAT THE GEAR PIN THAT PINS THE GEAR TO THE DRIVE SHAFT WAS SHEARED. THE COMPLAINT IS CONFIRMED. THE MOST LIKELY CAUSE OF THE COMPLAINT IS DETERMINED TO BE EXCESSIVE FORCE TO THE DRIVER. THE INSTRUCTIONS FOR USE STATES: "AVOID UNDUE STRESS OR STRAIN WHEN HANDLING OR CLEANING INSTRUMENTS."

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE DEVICE EVALUATION IS IN PROGRESS, A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE 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.

    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 WAS REPORTED THE INTERNAL GEARS OF THE DRIVER BROKE WHILE INSERTING SCREW CAUSING THE DRIVER TO NOT BE ABLE TO SPIN. THERE WAS NO INJURY TO THE PATIENT. THERE WAS ANOTHER DRIVER AVAILABLE TO COMPLETE THE SURGERY. THE SURGERY WAS NOT DELAYED, BUT SLOWED DOWN DUE TO ONLY HAVING ONE USABLE DRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268588 BIOMET MICROFIXATION FACIAL PLATING SYSTEM 90 DEGREE CONTRA ANGLE SCREWDRIVER HRS BIOMET MICROFIXATION N/A 081060

    Patients

    Seq Age Sex Outcome Treatment
    1