BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® TITANIUM HEXED SCREW

    MDR report key: 13017224 · Received December 16, 2021

    Report

    Report Number
    0001038806-2021-02376
    Event Type
    Malfunction
    Date Received
    December 16, 2021
    Date of Event
    November 25, 2021
    Report Date
    May 17, 2022
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868008545
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). ONE CERTAIN® TITANIUM HEXED SCREW, IUNIHT WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION VIA NAKED EYE AND CAMERA MAGNIFICATION CONFIRMED SCREW WAS FRACTURED AT THREADS. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER FORM. THE REPORTED DEVICE WAS LOCATED ON TOOTH SITE 14 (FDI) AND THE LENGTH OF TIME USED WAS 7 MONTHS. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: BIOMET 3I RESTORATIVE PRODUCTS IFU (P-IIS086GR) REV F - OCTOBER 2019. INFORMATION IDENTIFIED: 'PRECAUTIONS' 'BREAKAGE' 'WARNING'. 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: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1212052). 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: A COMPLAINT HISTORY REVIEW CONDUCTED FOR THE SUBJECT LOT NUMBER (1212052). THE REVIEW REVEALED THAT THERE ARE NO EXISTING NONCONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED DEVICE RELATED TO THE REPORTED EVENT FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: FRACTURE SCREW). POST MARKET TREND REVIEW: MARCH POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (FRACTURE SCREW) AND DEVICE (IUNIHT). MALF/EVENT: BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED FOLLOWING INSPECTION AND EVALUATION.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCREW FAILED DUE TO A FRACTURE. PATIENT WOULD HAVE TO RETURN TO PLACE A NEW SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919033 CERTAIN® TITANIUM HEXED SCREW DENTAL SCREW NHA BIOMET 3I IUNIHT 1212052 00844868008545

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female