BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.8X50MM DRILL 26MM STOP

    MDR report key: 12467185 · Received September 14, 2021

    Report

    Report Number
    0001032347-2021-00434
    Event Type
    Malfunction
    Date Received
    September 14, 2021
    Date of Event
    July 28, 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

    D4: UDI. 4 POTENTIAL LOT #'S WERE PROVIDED FROM THE VENDOR LOT. UDI FOR THESE LOTS ARE AS FOLLOWS: (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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D9; G3; G6; H1; H2; H3; H6, H10 A VISUAL INSPECTION WAS COMPLETED ON THE RETURNED 24-2050 VENDOR LOT 347291. VISUAL INSPECTION OF THE RETURNED DRILL CONFIRMED DRILL FRACTURE. THE DEVICE APPEARS TO BEEN BENT AT THE BREAKING POINT. A DETERMINATION CANNOT BE MADE AS TO WHAT CAUSED THE FRACTURE. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. 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.

    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.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). REPORT SOURCE: (B)(6). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL FRACTURED WHEN USED ON THE PATIENT'S LOWER JAW. THE PROCEDURE 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
    1368016 1.8X50MM DRILL 26MM STOP DRILL HBE BIOMET MICROFIXATION N/A 101390, 199570, 808940, 061620

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown