BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIBFIX BLU SCR S/D-LK 2.4X12MM

    MDR report key: 21048052 · Received December 31, 2024

    Report

    Report Number
    0001032347-2024-00409
    Event Type
    Injury
    Date Received
    December 31, 2024
    Date of Event
    October 24, 2024
    Report Date
    March 20, 2025
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    UDI-DI
    00888233001243
    PMA / PMN Number
    K142823
    Adverse Event
    Yes
    Product Problem
    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. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G3, G6, H2, H3, H4, H6, H10, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS UNCONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). D10 ¿ MEDICAL PRODUCTS: ITEM #76-2408, LOT #J7660149; RIBFIX BLU SCR S/D-LK 2.4X8MM; QTY (B)(4). ITEM #76-2408; LOT #J7690448; RIBFIX BLU SCR S/D-LK 2.4X8MM; QTY (B)(4). ITEM #76-2412, LOT #040670; RIBFIX BLU SCR S/D-LK 2.4X12MM; QTY (B)(4). ITEM #76-2412, LOT #933640 RIBFIX BLU SCR S/D-LK 2.4X12MM; QTY (B)(4). ITEM # 76-2601, LOT #J7720232; RIBFIX BLU 8 HOLE STRAIGHT PLT; QTY (B)(4). G2: FOREIGN SOURCE: JAPAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    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 AN INITIAL SURGERY DURING WHICH THE SURGEON CUT BOTH ENDS OF THE PLATES AND FIXED WITH TWO SCREWS. SUBSEQUENTLY, THE PLATES AND UNKNOWN QUANTITY OF SCREWS WERE REMOVED DUE TO POOR FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116338 RIBFIX BLU SCR S/D-LK 2.4X12MM SCREW, FIXATION, BONE HWC BIOMET MICROFIXATION N/A 933640 00888233001243

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11.