BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TW DRILL 1.1X50MM 15MMSTP W/NT

    MDR report key: 12780794 · Received November 9, 2021

    Report

    Report Number
    0001032347-2021-00529
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 6, 2021
    Report Date
    November 30, 2022
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    PMA / PMN Number
    K062842
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 6 POSSIBLE LOT #'S WERE PROVIDED BASED ON THE VENDOR LOT. THE UDI #'S FOR THESE LOTS ARE AS FOLLOWS: 894080:(B)(4); 894040:(B)(4); 894030:(B)(4); 894000:(B)(4); 893980:(B)(4); 275150:(B)(4). IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    D4: THERE ARE SIX (6) POSSIBLE LOTS: 894080, 894040, 894030, 894000, 893980, 275150 A VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED TWIST DRILL. THE TWIST DRILL SHOWS SINGS OF USE INCLUDING SCRATCHING ON THE DRILL BASE. THE DRILL HAS FRACTURED WHERE THE DRILL BASE MEETS THE FLUTED DRILL PORTION. THE FLUTED PORTION WAS NOT RETURNED FOR INVESTIGATION. REVIEW OF THE SUPPLIER CERTS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A SUPPLIER DHR REVIEW WAS NOT REQUESTED AS CERTS SHOW 100% PRODUCT INSPECTION AND HARDNESS TESTING BEING CONDUCTED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE: FOREIGN - (B)(6). 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DRILL TIP FRACTURED DURING A PROCEDURE TO EXTEND THE MIDFACE OF THE MAXILLA. THE SURGERY WAS COMPLETED WITH ANOTHER DRILL. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676480 TW DRILL 1.1X50MM 15MMSTP W/NT DRILL HBE BIOMET MICROFIXATION N/A SEE H10 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown