BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.8X5MM HT X-DR SCR

    MDR report key: 17171963 · Received June 21, 2023

    Report

    Report Number
    0001032347-2023-00239
    Event Type
    Injury
    Date Received
    June 21, 2023
    Date of Event
    March 28, 2023
    Report Date
    August 30, 2024
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    UDI-DI
    00841036056254
    PMA / PMN Number
    K121589
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: THE PREVIOUSLY REPORTED LOT NUMBER WAS DETERMINED TO BE INCORRECT BY INVENTORY TRANSACTION HISTORY. THEREFORE, IT IS BEING CHANGED TO UNKNOWN. THIS REPORT IS BEING SUBMITTED TO UPDATE AND CORRECT ADDITIONAL INFORMATION IN SECTIONS B4, B5, D4, G3, G6, H2, H6, AND H10.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). D10 ¿ MEDICAL PRODUCTS ITEM # 01-6482, LOT # 161370; 1.5/0.6 2MM LEFORT PLATE; QTY 2. ITEM # 95-1805, LOT # 273127F; 1.8X5MM HT X-DR SCREW. ITEM # 95-1505, LOT # 273727F; 1.5X5MM HT X-DR SCREW; QTY 21. G2: FOREIGN: JAPAN. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2023-00237; 0001032347-2023-00238; 0001032347-2023-00240; 0001032347-2023-00241; 0001032347-2023-00242; 0001032347-2023-00243; 0001032347-2023-00244; 0001032347-2023-00245; 0001032347-2023-00246; 0001032347-2023-00247; 0001032347-2023-00248; 0001032347-2023-00249; 0001032347-2023-00250; 0001032347-2023-00251; 0001032347-2023-00252; 0001032347-2023-00253; 0001032347-2023-00254; 0001032347-2023-00255; 0001032347-2023-00256; 0001032347-2023-00257; 0001032347-2023-00258; 0001032347-2023-00259; 0001032347-2023-00260

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REVIEW OF CUSTOMER-PROVIDED PHOTOS SHOWS FRACTURES OF TWO PLATES. NO DEFECTS COULD BE CONFIRMED ON THE PHOTOS OF THE 22 REPORTED SCREWS. AS THE REASON FOR REVISION IS UNKNOWN, NO CONCLUSIONS CAN BE MADE BY THESE PHOTOS. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED FOR THE SCREWS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS UNCONFIRMED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTIONS B4, B5, G3, G6, H2, H3, H6, AND H10.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. A VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED PLATES AND SCREWS. BOTH PLATES AND THE SCREWS SHOW SIGNS OF ATTEMPTED USE INCLUDING MARKING AND SCRATCHING ON THE PRODUCT SURFACES. BOTH PLATES HAVE FRACTURED. THE RETURNED DEVICES WERE EVALUATED WITH OPTICAL MICROSCOPY AND SCANNING ELECTRON MICROSCOPY. SEM IMAGES OF THE FRACTURE SURFACES OF THE TWO PLATES SHOW FATIGUE STRIATIONS, SUGGESTING THE FATIGUE FAILURE MODE. SEMI QUANTITATIVE EDS ELEMENTAL ANALYSIS FOUND THE MATERIAL TO BE CONSISTENT WITH TITANIUM WITH MINOR CARBON CONTAMINATION. FOR THE 22 RETURNED SCREWS ALL SCREWS SHOW SIGNS OF LIGHT USE WITH MINOR MARKING ON THE SCREW SURFACES. ALL SCREWS HOWEVER ARE INTACT WITH NO SIGNS OF DAMAGE. THE SCREWS ARE FULLY FUNCTIONAL WITH NO ISSUES FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS CONFIRMED, BASED ON PRODUCT RETURN.

    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 IS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE, AND SUBSEQUENTLY WAS REVISED FOR AN UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987938 1.8X5MM HT X-DR SCR PLATE, BONE JEY BIOMET MICROFIXATION N/A 273127F 00841036056254

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H10.