BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET MICROFIXATION FACIAL PLATING SYSTEM

    MDR report key: 6700705 · Received July 11, 2017

    Report

    Report Number
    0001032347-2017-00541
    Event Type
    Malfunction
    Date Received
    July 11, 2017
    Date of Event
    June 9, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCREWDRIVERS WERE RETURNED WITHOUT PACKAGING. THE INSTRUMENTS WERE VISUALLY EVALUATED AND FOUND TO BE IN POOR OVERALL CONDITION. THERE WERE SCRATCHES AND NORMAL SIGNS OF WEAR ON THE INSTRUMENT; SIGNIFICANT DISCOLORATION WAS OBSERVED. THERE IS SOME FRICTION WHEN ROTATING THE KNOB ON BOTH DRIVERS. THE COMPLAINT WAS CONFIRMED AS THERE IS FRICTION WHILE ROTATING THE DRIVER. THE MOST LIKELY CAUSE OF THE COMPLAINT IS DETERMINED TO BE DUE TO CHEMICAL RESIDUAL BUILDING UP ON THE INTERNAL GEARING. IN THE STERILITY SECTION OF THE INSTRUCTIONS FOR USE IT IS STATED, ¿STAINING AND SPOTTING MAY RESULT ON INSTRUMENTS THAT ARE STEAM STERILIZED IF THE INSTRUMENTS ARE NOT COMPLETELY RINSED AND FREE FROM RESIDUAL CHEMICALS. IT IS VITAL THAT PROPER DRYING CYCLES AND THE EQUIPMENT MANUFACTURER¿S RECOMMENDATIONS ARE FOLLOWED TO PREVENT THE FORMATION OF EXCESS MOISTURE AND RESULTANT WATER SPOTTING.¿ THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS SUPPLEMENTAL REPORT ONE OF TWO. REPORT TWO OF TWO IS REPORTED ON MFR #:0001032347-2017-00542-2.

    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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2017-00542-3.

    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. THIS IS REPORT ONE OF TWO. REPORT TWO OF TWO IS REPORTED ON MFR #:0001032347-2017-00542.

    Additional Manufacturer Narrative · 1

    DATE OF THIS REPORT CORRECTED TO REFLECT JUL 11, 2017. THIS IS REPORT ONE OF TWO. REPORT TWO OF TWO IS REPORTED ON MFR #:0001032347-2017-00542.

    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 THAT TWO CONTRA ANGLE DRIVERS WERE INSPECTED BY A SCRUB TECHNICIAN WHEN THEY BEGAN TO MALFUNCTION. IT IS STATED THE APPROPRIATE SURGICAL TECHNIQUE WAS FOLLOWED. THERE WAS NO INJURY TO THE PATIENT. THE EVENT CAUSED A DELAY OF FIFTEEN MINUTES TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481723 BIOMET MICROFIXATION FACIAL PLATING SYSTEM 90 DEGREE CONTRA ANGLE SCREWDRIVER HRS BIOMET MICROFIXATION N/A 580850

    Patients

    Seq Age Sex Outcome Treatment
    1