BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM HEXED UNISCREW

    MDR report key: 17006085 · Received May 25, 2023

    Report

    Report Number
    0001038806-2023-01018
    Event Type
    Malfunction
    Date Received
    May 25, 2023
    Date of Event
    April 11, 2023
    Report Date
    November 13, 2023
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868017318
    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

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ZIMVIE RECEIVED ONE (1) UNIHT, (TITANIUM HEXED UNISCREW) FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED, A FRACTURE HAS BEEN IDENTIFIED AT THE THREADS. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1210940. NO DEVIATIONS OR NON-CONFORMANCE'S, 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 1210940 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DENTAL : FUNCTIONAL : FRACTURE : SCREW BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WERE MATERIAL SELECTION OF THE PRODUCT IS NOT ADEQUATE TO WITHSTAND OCCLUSAL FORCES. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE FRACTURE HAS BEEN IDENTIFIED ON THE THREADS. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE 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

    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 SCREWS FRACTURED AT THE THREADS AND WERE REMOVED. PROCEDURE WAS COMPLETED PLACING NEW SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727181 TITANIUM HEXED UNISCREW DENTAL SCREW NHA BIOMET 3I UNIHT 1210940 00844868017318

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose