BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL MANDIBULAR SYSTEM 1.8X50MM DRILL, 26MM STOP

    MDR report key: 10120179 · Received June 4, 2020

    Report

    Report Number
    0001032347-2020-00260
    Event Type
    Malfunction
    Date Received
    June 4, 2020
    Date of Event
    May 28, 2020
    Report Date
    September 22, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    UDI-DI
    00841036059279
    PMA / PMN Number
    K062842
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS CONFIRMED. A VISUAL INSPECTION WAS CARRIED OUT ON THE TWO DRILLS. ONE OF THE TWO DRILLS WAS BENT AT A 45 DEGREE ANGLE WHILE THE OTHER DRILL WAS FRACTURED INTO TWO PIECES. THE RAW MATERIAL CERT WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS THE ONLY COMPLAINT IN REGARDS TO THE DRILL FRACTURING/ BENDING OF 24-2050 LOT 321017. THE MOST LIKELY UNDERLYING CAUSE IS EXCESSIVE FORCE WAS APPLIED BEYOND WHAT THE PRODUCT IS DESIGNED TO ENCOUNTER. IT IS POSSIBLE OFF AXIS DRILLING OCCURRED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING FIELDS WERE UPDATED: D4 LOT NUMBER - BASED ON A REVIEW OF INVENTORY TRANSACTIONS AND THIS CUSTOMER'S PURCHASE HISTORY, THERE ARE SEVEN (7) POSSIBLE LOT NUMBERS: 895130, 895240, 229460, 418120, 418100, 895210, AND 895220.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. FOREIGN REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DRILL BIT FRACTURED AND ONE DRILL BIT BENT DURING A PROCEDURE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585145 TOTAL MANDIBULAR SYSTEM 1.8X50MM DRILL, 26MM STOP DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE BIOMET MICROFIXATION N/A SEE H10 NARRATIVE 00841036059279

    Patients

    Seq Age Sex Outcome Treatment
    1