BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 7MM STOP

    MDR report key: 10538758 · Received September 15, 2020

    Report

    Report Number
    0001032347-2020-00443
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    August 28, 2020
    Report Date
    October 27, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    UDI-DI
    00841036013165
    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 PART NUMBER 01-7144 TW DRILL 1.1X50MM 7MMSTOP W/NT VENDOR LOT 186734 WAS RETURNED FOR EVALUATION. ON VISUAL INSPECTION, THE DRILL WAS NOTED TO HAVE A TRANSVERSE FRACTURE THROUGH THE FLUTES NEAR THE NECK, THEREFORE THE TIP OF THE DRILL ITSELF WAS NOT RETURNED. THE CERT WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS THE ONLY COMPLAINT IN REGARDS TO THE DRILL FRACTURING FOR PART 01-7144 VENDOR LOT 186734. 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 D10 DEVICE AVAILABILITY 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. LOT NUMBER - BASED ON A REVIEW OF INVENTORY TRANSACTIONS AND THE CUSTOMER'S PURCHASE HISTORY, THERE ARE TWO POSSIBLE LOTS: 144370, 842090. 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 THAT A FRACTURED DRILL TIP WAS DISCOVERED DURING AN ORAL SURGERY. IT WAS CONFIRMED BY X-RAY THAT NO FRACTURED PIECE OF DRILL REMAINS IN THE ORAL CAVITY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002554 1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 7MM STOP DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE BIOMET MICROFIXATION N/A SEE H10 NARRATIVE 00841036013165

    Patients

    Seq Age Sex Outcome Treatment
    1