BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET MICROFIXATION FACIAL PLATING SYSTEM

    MDR report key: 6518950 · Received April 25, 2017

    Report

    Report Number
    0001032347-2017-00306
    Event Type
    Malfunction
    Date Received
    April 25, 2017
    Date of Event
    March 16, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    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 WAS SEEN TO BE IN GOOD CONDITION WITH MINIMAL SIGNS OF WEAR. THE DRIVER WAS FUNCTIONALLY TESTED BY INSERTING A SCREW WITH A CONTRA-ANGLE BLADE INTO POPLAR. THE DRIVER WAS ABLE TO SUCCESSFULLY SEAT THE SCREW. THE COMPLAINT FOR THE BROKEN DRIVER COULD NOT BE DETERMINED AS THE DRIVER FUNCTIONED AS INTENDED.

    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.

    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 DRIVER FELT LIKE IT WAS GRINDING DURING A PROCEDURE. THE SURGEON WAS TURNING THE BOTTOM HANDLE AND THEN THE BOTTOM GEAR BROKE WHILE TIGHTENING. A BACKUP WAS USED TO COMPLETE THE SURGERY WITH A TWO MINUTE DELAY. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299598 BIOMET MICROFIXATION FACIAL PLATING SYSTEM 90 DEGREE CONTRA ANGLE SCREWDRIVER HRS BIOMET MICROFIXATION N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1