BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® TITANIUM LARGE HEXED SCREW

    MDR report key: 12547309 · Received September 29, 2021

    Report

    Report Number
    0001038806-2021-01835
    Event Type
    Malfunction
    Date Received
    September 29, 2021
    Date of Event
    August 18, 2021
    Report Date
    February 22, 2022
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    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

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE (1) CERTAIN® TITANIUM LARGE HEXED SCREW (ILRGHT) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THE SCREW FRACTURED ACROSS THE THREADS. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1230880). 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, WERE NOTED AS PART OF THE DHR. LOT NUMBERS WERE INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1230880) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS FRACTURE SCREW. 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 COMPLAINT NUMBER (B)(4). PMA/510(K) NUMBER K072642.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROSTHETIC SCREW WAS FRACTURED. THE DOCTOR ALSO CONFIRMED THAT THE DENTAL SURGICAL PROCEDURE WAS COMPLETED WITH ANOTHER SCREW AND THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON HIS HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1444020 CERTAIN® TITANIUM LARGE HEXED SCREW DENTAL SCREW DZE BIOMET 3I ILRGHT 1230880 00844868006138

    Patients

    Seq Age Sex Outcome Treatment
    1 Female