BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEX-THREAD DISTAL FIBULA INTRAMEDULLARY NAIL SYSTEM (5.5MM NAIL & 1.0MM END CAP

    MDR report key: 22494397 · Received July 14, 2025

    Report

    Report Number
    MW5172550
    Event Type
    Injury
    Date Received
    July 14, 2025
    Date of Event
    March 28, 2025
    Report Date
    July 8, 2025
    Manufacturer
    FLOWER ORTHOPEDICS CORPORATION DBA CONVENTUS FLOWER
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE SURGEON PLANNED TO PERFORM AN ORIF (OPEN REDUCTION AND INTERNAL FIXATION (ORIF)) OF THE PATIENT'S FIBULA USING THE FLOWER ORTHOPEDICS FIBULAR NAIL SYSTEM. THE DRILL BIT SHATTERED IN THE BONE CAUSING THE SURGEON TO HAVE IT CLEANED OUT AND CHANGE THE APPROACH TO THE ORIF USING A PLATE AND SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129333 FLEX-THREAD DISTAL FIBULA INTRAMEDULLARY NAIL SYSTEM (5.5MM NAIL & 1.0MM END CAP ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB FLOWER ORTHOPEDICS CORPORATION DBA CONVENTUS FLOWER 8528-1 BG2982201E

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention