BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN GOLD-TITE HEXED SCREW

    MDR report key: 11494450 · Received March 16, 2021

    Report

    Report Number
    0001038806-2021-00439
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Report Date
    July 1, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868008538
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY DEVICE EVALUATION AND ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: D10: ILDAT4-CERTAIN® BELLATEK® TITANIUM ABUTMENT 4.1MM-LOT# 8605374-1 H6: COMPONENT CODE WAS ADDED: 4755. H6: INVESTIGATION TYPE CODES WERE ADDED: 3331, 4109, 4110. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODES WERE ADDED: 4315. THE PRODUCT WAS RETURNED AND THE REPORTED EVENT (FRACTURED: SCREW) COULD NOT BE VERIFIED DUE TO THE AS-RETURNED CONDITION OF THE PRODUCT. BASED ON THE EVALUATION, THE DEVICE MALFUNCTION COULD NOT BE VERIFIED. HOWEVER, THERE IS NO EXISTING NONCONFORMANCE/CAPA/HHE/D/IE/PRODUCT HOLDS AGAINST THE REPORTED DEVICES THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. MONTHLY POST MARKET TRENDING REVIEW IDENTIFIED NO ADVERSE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS OR DEVICE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCTS WERE LIKELY WITHIN SPECIFICATIONS AND LIKELY CONFORMING WHEN THEY LEFT ZIMMER BIOMET. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER IUNIHG (1240760). 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. THE REPORTED EVENT IS RELATED TO THE FUNCTIONAL PERFORMANCE OF THE DEVICE AND CANNOT BE RECREATED DUE TO THE NATURE OF THE ALLEGED EVENT. BASED ON THE INVESTIGATION AND RISK REVIEW, THE MOST LIKELY CAUSE(S) FOR THE REPORTED EVENT IS CROSS THREADING. NO 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.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER: (B)(6).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY HAVE A BELLATEK ABUTMENT THAT HAD A BROKEN SCREW STUCK INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390567 CERTAIN GOLD-TITE HEXED SCREW DENTAL SCREW NHA BIOMET 3I IUNIHG 1240760 00844868008538

    Patients

    Seq Age Sex Outcome Treatment
    1 DENTAL ABUTMENT.