BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 15MM STOP

    MDR report key: 10895600 · Received November 24, 2020

    Report

    Report Number
    0001032347-2020-00584
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    November 5, 2020
    Report Date
    January 8, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    UDI-DI
    00841036013196
    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. THE DRILL WAS RETURNED FOR EVALUATION. ON VISUAL INSPECTION, THE DRILL WAS NOTED TO HAVE A TRANSVERSE FRACTURE THROUGH THE FLUTES NEAR THE NECK. THE CERTIFICATE OF CONFORMANCE WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES WERE FOUND. THERE IS NO INDICATION OF A MANUFACTURING DEFECT. THIS IS THE ONLY COMPLAINT IN REGARDS TO THE DRILL FRACTURING FOR 01-7148 VENDOR LOT 318909. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT IS THE DRILL EXPERIENCED FORCE IN EXCESS OF WHAT IT WAS DESIGNED TO ENCOUNTER; FRACTURES AT THIS POINT OF THE DRILL ARE TYPICAL OF EXCESSIVE FORCE FRACTURES. 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. THE FOLLOWING FIELDS WERE UPDATED: B4 DATE OF THIS REPORT; B5 DESCRIBE EVENT OR PROBLEM; G4 DATE RECEIVED BY MANUFACTURER; G7 TYPE OF REPORT; H2 FOLLOW UP TYPE; H3 DEVICE EVALUATED BY MANUFACTURER; H6 METHOD CODE; H6 RESULTS CODE; H6 CONCLUSIONS CODE; H10 ADDITIONAL NARRATIVES/DATA.

    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 LOT NUMBER PROVIDED BY THE CUSTOMER IS THE VENDOR¿S LOT NUMBER. FOLLOWING A REVIEW OF THE CUSTOMER¿S PURCHASE HISTORY, THERE ARE SEVEN (7) POSSIBLE LOT NUMBERS: 894000, 894040, 893980, 894080, 894030, 123460, 275150. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DRILL FRACTURED NEAR THE NECK OF THE BIT DURING A MAXILLARY FIXATION PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DRILL. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357077 1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 15MM STOP DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE BIOMET MICROFIXATION N/A SEE H10 NARRATIVE 00841036013196

    Patients

    Seq Age Sex Outcome Treatment
    1