BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0 LACTOSORB SYSTEM 2.0 X 7MM LACTOSORB SCREW

    MDR report key: 10483616 · Received September 2, 2020

    Report

    Report Number
    0001032347-2020-00410
    Event Type
    Malfunction
    Date Received
    September 2, 2020
    Date of Event
    August 13, 2020
    Report Date
    October 26, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    UDI-DI
    00841036195267
    PMA / PMN Number
    K992355
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT CANNOT BE VERIFIED. FUNCTIONAL TESTING AND INSPECTIONS COULD NOT BE PERFORMED DUE TO THE PRODUCT NOT BEING RETURNED AND NO PHOTOGRAPHS BEING PROVIDED. THE DHR WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS THE ONLY COMPLAINT IN REGARDS TO THE SCREW FRACTURING FOR 915-2301-EA LOT 850200. THE MOST LIKELY UNDERLYING CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE SCREW FRACTURED DURING INSERTION. THE PROCEDURE WAS COMPLETED WITH ALTERNATE SCREWS. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945474 2.0 LACTOSORB SYSTEM 2.0 X 7MM LACTOSORB SCREW SCREW, FIXATION, BONE HWC BIOMET MICROFIXATION N/A 850200 00841036195267

    Patients

    Seq Age Sex Outcome Treatment
    1