BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN TITANIUM HEXED SCREW

    MDR report key: 20745363 · Received November 21, 2024

    Report

    Report Number
    0001038806-2024-02710
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Report Date
    March 30, 2025
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ZIMVIE DID NOT RECEIVE ONE (1) IUNIHT, (CERTAIN TITANIUM HEXED SCREW) FOR EVALUATION. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM NUMBER, DEVICE HISTORY RECORD (DHR) REVIEW, AND RISK MANAGEMENT FILE (RMF). DHR REVIEW BY LOT NUMBER COULD NOT BE PERFORMED, AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT IS NOT AVAILABLE. HOWEVER, ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE IUNIHT DATING BACK TO 12 MONTHS FROM NOW. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/PRODUCT HOLDS FOR THE REPORTED PRODUCT FOR SIMILAR EVENT. REVIEW COMPLETED UTILIZING KEYWORDS: ¿DENTAL : FUNCTIONAL : FRACTURE : SCREW¿ THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RM-00057-HAZ, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS THE TORQUE APPLIED DURING PLACEMENT/ SEATING EXCEEDED RECOMMENDED VALUE. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION WAS NOT ESTABLISHED. WITHOUT DEVICE RECEIPT, THE REPORTED EVENT IS NON-VERIFIABLE. 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. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT G3: DATE RECEIVED BY MANUFACTURER G6: CHECKED "FOLLOW-UP" H3: CHANGED "YES" TO "NO" H6: ENTERED EVALUATION CODES H10: ADDED MANUFACTURER NARRATIVE H3 OTHER TEXT : DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SCREW FRACTURED IN THE PATIENT'S MOUTH. BROKEN PORTION STILL IN IMPLANT. REFERRED TO ORAL SURGEON FOR REMOVAL. TOP PORTION DISCARDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2427370 CERTAIN TITANIUM HEXED SCREW DENTAL SCREW NHA BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown