BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET MICROFIXATION FACIAL PLATING SYSTEM

    MDR report key: 6486389 · Received April 12, 2017

    Report

    Report Number
    0001032347-2017-00269
    Event Type
    Malfunction
    Date Received
    April 12, 2017
    Date of Event
    March 13, 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

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS IN PROGRESS, A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. .

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTITY WAS CONFIRMED IN THE EVALUATION. THE DRIVER WAS VISUALLY EVALUATED AND SHOWS SIGNS OF NORMAL USE AND A STUCK BLADE. THE DRIVER WAS FUNCTIONALLY TESTED AND DETERMINED TO HAVE A ROUGH ROTATION. THE DRIVE SHAFT WAS SLIGHTLY BENT, CAUSING ECCENTRIC ROTATION AND ROUGH MESHING OF THE GEARS. THE MOST LIKELY CAUSE OF THE COMPLAINT IS EXCESSIVE FORCE CAUSING THE DRIVE SHAFT TO DEFLECT. THE INSTRUCTIONS FOR USE STATES, "AVOID UNDUE STRESS OR STRAIN WHEN HANDLING OR CLEANING INSTRUMENTS." THE DEVICE HISTORY RECORD WAS REVIEWED AND THERE ARE NO NON CONFORMANCES ASSOCIATED WITH THIS LOT.

    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
    268760 BIOMET MICROFIXATION FACIAL PLATING SYSTEM 90 DEGREE CONTRA ANGLE SCREWDRIVER HRS BIOMET MICROFIXATION N/A 465660

    Patients

    Seq Age Sex Outcome Treatment
    1