BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMNET MICROFIXATION FACIAL PLATING SYSTEM

    MDR report key: 5973828 · Received September 23, 2016

    Report

    Report Number
    0001032347-2016-00529
    Event Type
    Malfunction
    Date Received
    September 23, 2016
    Date of Event
    August 16, 2016
    Report Date
    December 7, 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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    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 PRODUCTS WERE RETURNED FOR EVALUATION. THE PRODUCT IDENTITIES WERE CONFIRMED IN THE EVALUATION. THE DRIVERS WERE VISUALLY EVALUATED AND THEY BOTH SHOW SIGNS OF NORMAL USE. THE DRIVERS WERE FUNCTIONALLY TESTED AND FOUND NOT TO FUNCTION AS INTENDED. THEREFORE, THE COMPLAINT FOR BOTH DRIVERS WAS CONFIRMED. THE MOST-LIKELY CAUSE WAS DETERMINED TO BE EXCESSIVE TORQUE APPLIED TO THE DRIVERS. THE DEVICE HISTORY RECORDS WERE REVIEWED IN THE EVALUATION AND NO NON-CONFORMANCES WERE FOUND.

    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. (B)(4).

    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.

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTED WHILE ATTEMPTING TO FIXATE THE PATIENT, TWO DRIVERS DID NOT FUNCTION PROPERLY. THE DRIVERS WERE TURNING BUT THE BLADES WERE NOT. THE SURGEON WAS ABLE TO ACCESS THE THIRD AND FOURTH POSTERIOR RIB FRACTURES MANUALLY AND FIXATE THE PATIENT SUCCESSFULLY. NO DELAY OR PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624957 BIOMNET MICROFIXATION FACIAL PLATING SYSTEM 90 DEG CONTRA ANGLE SCREWDRIVER HRS BIOMET MICROFIXATION N/A 417430

    Patients

    Seq Age Sex Outcome Treatment
    1