BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACTO SCR 2.0X7MM 2.0 SYS 2/PK

    MDR report key: 21048208 · Received December 31, 2024

    Report

    Report Number
    0001032347-2024-00414
    Event Type
    Malfunction
    Date Received
    December 31, 2024
    Date of Event
    December 4, 2024
    Report Date
    April 25, 2025
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    UDI-DI
    00841036055028
    PMA / PMN Number
    K002083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). D10 ¿ MEDICAL PRODUCTS : ITEM #915-2308-EA, LOT #068090; LACTO SCR 2.5X7MM 2.0 SYS 1PK. G3: 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTIONS B4, B5, E1, E2, E3, G3, G6, H2, AND H11.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE SURGEON USED A 7MM SCREW AFTER PERFORMING THE DRILLING AND TAPPING AS USUAL, BUT COULD NOT FIX THE SCREW CORRECTLY. HE THEN SWITCHED TO AN EMERGENCY SCREW, BUT IT DID NOT REACH THE PLANNED POSITION, AND THIS EMERGENCY SCREW ALSO FAILED TO FIXATE CORRECTLY. THEREFORE, THE SURGEON DECIDED TO SWITCH TO A TITANIUM PLATE TO COMPLETE THE SURGERY.

    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 AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206915 LACTO SCR 2.0X7MM 2.0 SYS 2/PK SCREW, FIXATION, BONE HWC BIOMET MICROFIXATION N/A 66053354 00841036055028

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11.