BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM SYSTEM TWIST DRILL CONTRA 1.5MM X 30.5MM W/ 15.5MM STOP

    MDR report key: 10895585 · Received November 24, 2020

    Report

    Report Number
    0001032347-2020-00583
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    November 5, 2020
    Report Date
    July 7, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    UDI-DI
    00841036016890
    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. TWO OF ITEM 01-9181 CONTRA DRILL 1.5X15.5MM STP WERE RETURNED. VISUAL EVALUATION OF THE DRILLS SHOWS THAT THE BITS FRACTURED IN THE FLUTED SECTION OF THE DRILL BITS. NO OTHER ANOMALIES COULD BE IDENTIFIED. DEVICE HISTORY RECORDS WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION 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

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2021-00355. D11: ITEM# 01-9181; LOT# M054140, M101640, M049140, M659010, OR M896130.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    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. REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DRILL FRACTURED NEAR THE NECK OF THE DRILL TIP WHILE DRILLING THE MANDIBLE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DRILL BIT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356145 2.0MM SYSTEM TWIST DRILL CONTRA 1.5MM X 30.5MM W/ 15.5MM STOP DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE BIOMET MICROFIXATION N/A 133310 00841036016890

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE NARRATIVE IN H10.