BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET MICROFIXATION FACIAL PLATING SYSTEM

    MDR report key: 6417747 · Received March 20, 2017

    Report

    Report Number
    0001032347-2017-00210
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Date of Event
    February 17, 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
    OH, 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; G5 PMA/510(K) NUMBER: K121589, CORRECTED TO K142823. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2017-00200-2.

    Additional Manufacturer Narrative · 1

    DRIVER LOT # 801390 HAD A VERY ROUGH ROTATION WHEN OPERATED INDICATING EXCESS FRICTION BETWEEN THE MESHING GEARS. THE DRIVER HEAD WAS REMOVED TO INSPECT THE GEARS AND THERE WAS A LARGE AMOUNT OF FOREIGN MATERIAL ON THE DRIVE SHAFT GEAR FACE THAT WAS CAUSING THE GEARS NOT TO MESH CORRECTLY. THE DRIVER WAS FUNCTIONALLY TESTED AND CONFIRMED TO NOT TRANSMIT ANY TORQUE TO THE BLADE. FURTHER INSPECTION REVEALED THE MAIN GEAR ON THE DRIVE SHAFT HAD SHEARED THE DOWEL PIN THAT LOCKED IT IN PLACE AND IT WAS ABLE TO SPIN FREELY ON THE DRIVE SHAFT. THE MOST LIKELY CAUSE OF THIS IS EXCESSIVE TORQUE. THERE ARE NO SIGNS OF MANUFACTURING DEFECTS. SUPPLEMENTAL REPORT TWO OF TWO FOR THE SAME EVENT, REFERENCE REPORT 0001032347-2017-00200-1.

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT 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. REPORT TWO OF TWO FOR THE SAME EVENT, REFERENCE REPORT 0001032347-2017-00200.

    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 GEAR IN TWO DRIVERS BROKE DURING A RIB FRACTURE CASE. A BACK UP DRIVER WAS USED TO COMPLETE THE SURGERY; THERE WAS NO DELAY OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201281 BIOMET MICROFIXATION FACIAL PLATING SYSTEM 90 DEGREE CONTRA ANGLE SCREWDRIVER HRS BIOMET MICROFIXATION N/A 801390

    Patients

    Seq Age Sex Outcome Treatment
    1