BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD-TITE HEXED UNISCREW

    MDR report key: 20703821 · Received November 18, 2024

    Report

    Report Number
    0001038806-2024-02658
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    September 1, 2024
    Report Date
    March 24, 2025
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868017301
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER: (B)(4). ZIMVIE RECEIVED ONE (1) UNIHG, (GOLD-TITE HEXED UNISCREW) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE SCREW WITH SIGNS OF USE AND WAS OBSERVED FRACTURED AT THE HEAD. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1231929. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1231929 FOR SIMILAR EVENTS AND ONE (1) OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: FRACTURE SCREW. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE EXCESSIVE OCCLUSAL FORCES, OR CUSTOMER ERROR. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE REPORTED EVENT WAS CONFIRMED WITH ALL THE AVAILABLE INFORMATION. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). D4: ADDITIONAL DEVICE INFORMATION UNKNOWN / NOT PROVIDED. H4: DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    THE DOCTOR REPORTS THAT THE FIXATION SCREW LOCATED IN POSITION NUMBER #24 FAILED BECAUSE IT FRACTURED BY THE HEAD. THE DOCTOR REPORTS THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER SCREW. PATIENT WITH BONE TYPE: III.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2591379 GOLD-TITE HEXED UNISCREW DENTAL SCREW NHA BIOMET 3I 1231929 00844868017301

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female