BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN¿ TITANIUM LARGE HEXED SCREW

    MDR report key: 15540220 · Received October 4, 2022

    Report

    Report Number
    0001038806-2022-01501
    Event Type
    Malfunction
    Date Received
    October 4, 2022
    Date of Event
    August 24, 2022
    Report Date
    February 27, 2023
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868006138
    PMA / PMN Number
    K972444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). PMA/510K: ADDITIONAL 510(K) NUMBER IS K072642.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE CERTAIN® TITANIUM LARGE HEXED SCREW, ILRGHT WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION VIA NAKED EYE AND CAMERA MAGNIFICATION CONFIRMED THAT THE SCREW WAS FRACTURED AT THE THREADS AND THE THREADED PORTION WAS NOT RETURNED. SIGNS OF USE WERE OBSERVED. 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 COMPLAINT. BONE DENSITY WAS TYPE II. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1251431). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCE'S, 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. A LOT SPECIFIC COMPLAINT HISTORY REVIEW WAS CONDUCTED FOR THE SUBJECT LOT NUMBER (1245768) AND REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCE'S/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED DEVICE RELATED TO THE REPORTED EVENT FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: FRACTURE SCREW). BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED FOLLOWING INSPECTION AND EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ABUTMENT SCREW FRACTURED AT THE SITE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SCREW.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2257568 CERTAIN¿ TITANIUM LARGE HEXED SCREW ABUTMENT SCREW NHA BIOMET 3I ILRGHT 1251431 00844868006138

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose