BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN TITANIUM LARGE HEXED SCREW

    MDR report key: 11855147 · Received May 20, 2021

    Report

    Report Number
    0001038806-2021-00869
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    April 25, 2021
    Report Date
    September 16, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). TWO CERTAIN® TITANIUM LARGE HEXED SCREW (ILRGHT X2) WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFY THAT THEY WERE FRACTURED ACROSS THE THREADS. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE PRODUCTS WERE FRACTURED. DEVICE HISTORY RECORD (DHR) REVIEW FOR THE LOTS (1242530 &1212216) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. LOTS WERE INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBERS (1242530 &1212216) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: FUNCTIONAL: FRACTURE: SCREW) AND 7 OTHER COMPLAINTS WERE IDENTIFIED. THEREFORE, 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). PREMARKET IDENTIFICATION PMA/510(K) NUMBER K072642.

    Description of Event or Problem · 1

    THE DOCTOR REPORTS FRACTURE OF THE SCREWS WITHOUT ANY KIND OF IMPACT TO THE PATIENT. THE AFFECTED DENTAL POSITIONS ARE #15 AND #17

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753291 CERTAIN TITANIUM LARGE HEXED SCREW DENTAL SCREW DZE BIOMET 3I ILRGHT 1242530 00844868006138

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR