BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN GOLD-TITE HEXED SCREW

    MDR report key: 11076384 · Received December 28, 2020

    Report

    Report Number
    0001038806-2020-02118
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Date of Event
    October 5, 2020
    Report Date
    March 25, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868008538
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES'. ONE CERTAIN GOLD-TITE HEXED SCREW (IUNIHG) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THAT IT WAS FRACTURED ACROSS THE THREADS. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE DEVICE WAS FRACTURED. PRE-EXISTING CONDITIONS WAS UNKNOWN DUE TO LIMITED INFORMATION PROVIDED BY CUSTOMER. HOWEVER, THE SCREW WAS PLACED ON THE TOOTH SITE 24 (FDI). X-RAY OR PICTURE IMAGES WERE NOT PROVIDED. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: BIOMET 3I RESTORATIVE PRODUCTS IFU (P-IIS086GR) REV F - OCTOBER 2019. PER THE APPLICABLE IFU, IT IS STATED THAT IMPROPER TECHNIQUE CAN LEAD TO DEVICE FAILURE. ADDITIONALLY, BREAKAGE MAY OCCUR WHEN DEVICE IS LOADED BEYOND ITS FUNCTIONAL CAPABILITY. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1211193. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1211193) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. JANUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (FUNCTIONAL: FRACTURE: SCREW) OR PRODUCT (IUNIHG). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. EMAIL ADDRESS UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SCREW PLACED FRACTURED AND WAS REMOVED. ADDITIONAL APPOINTMENT REQUIRED: YES, TO PLACE A NEW SCREW. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543597 CERTAIN GOLD-TITE HEXED SCREW DENTAL SCREW NHA BIOMET 3I IUNIHG 1211193 00844868008538

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR