BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN¿ TITANIUM LARGE HEXED SCREW

    MDR report key: 15896988 · Received December 1, 2022

    Report

    Report Number
    0001038806-2022-01840
    Event Type
    Malfunction
    Date Received
    December 1, 2022
    Date of Event
    November 7, 2022
    Report Date
    April 4, 2023
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    UDI-DI
    00844868006138
    PMA / PMN Number
    K972444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT; B5: DESCRIBE EVENT OR PROBLEM; D4: ADDITIONAL DEVICE INFORMATION; G3: DATE RECEIVED BY MANUFACTURER; G6: TYPE OF REPORT; H1: TYPE OF REPORTABLE EVENT; H2: FOLLOW UP TYPE; H3: DEVICE EVALUATED BY MANUFACTURER; H4: DEVICE MANUFACTURER DATE ; H6: ADVERSE EVENT PROBLEM; H10: ADDITIONAL NARRATIVE. FOUR CERTAIN® TITANIUM LARGE HEXED SCREWS (ILRGHT X 4) WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED FRACTURE ABOVE THE THREADS. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE DEVICES WERE FRACTURED. NO PRE-EXISTING CONDITION WAS NOTED ON THE PER. THE DEVICES WERE INTENDED FOR UNKNOWN TOOTH LOCATIONS. DHR REVIEW FOR THE LOTS (1251466 & 1249701) 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 ZIMVIE. LOTS WERE INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOTS (1251466 & 1249701) AND NO SIMILAR EVENT OR COMPLAINT WAS FOUND. (COMPLAINT CATEGORY KEYWORD: SCREW FRACTURE). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR, AND THE REPORTED EVENT WAS CONFIRMED FOLLOWING VISUAL EVALUATION.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4) PATIENT WEIGHT UNKNOWN / NOT PROVIDED. ADDITIONAL DEVICE INFORMATION UNKNOWN / NOT PROVIDED. REPORTER NAME AND ADDRESS UNKNOWN / NOT PROVIDED. PREMARKET IDENTIFICATION K072642. 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

    IT WAS REPORTED THAT THE 4 SCREW FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2828763 CERTAIN¿ TITANIUM LARGE HEXED SCREW DENTAL SCREW NHA BIOMET 3I ILRGHT 1249701 00844868006138
    347035 CERTAIN¿ TITANIUM LARGE HEXED SCREW DENTAL SCREW NHA BIOMET 3I ILRGHT 1249701 00844868006138

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female