BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSSIOFIBER TRIMMABLE FIXATION NAIL SYSTEM, CANNULATED

    MDR report key: 22529587 · Received July 17, 2025

    Report

    Report Number
    3014554088-2025-00003
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    June 24, 2025
    Report Date
    July 17, 2025
    Manufacturer
    OSSIO LTD.
    Product Code
    OJH
    UDI-DI
    07290017630250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPANY WAS INFORMED OF A GUIDE WIRE BREAKING INSIDE THE PATIENT'S BONE DURING INSERTION. SURGEON COULD NOT RETRIEVE THE BROKEN PART AND CLOSED THE SURGICAL SITE. AN INVESTIGATION WAS PERFORMED INCLUDING INTERNAL ANALYSIS OF RECORDS, PATIENT IMAGING, AND SURGEON FEEDBACK. THERE IS NO INDICATION OF A DESIGN, MANUFACTURING, STERILIZATION OR PROCESS ISSUE AFFECTING DEVICE SAFETY OR EFFECTIVENESS. IT WAS CONCLUDED THAT THIS EVENT WAS THE OUTCOME OF AN UNINTENDED USE ERROR OF THE DEVICE, WHICH RESULTED IN EXCESSIVE FORCES UPON INSERTION LEADING TO THE GUIDE WIRE BREAKAGE. THE INSTRUCTIONS FOR USE INCLUDE PRECAUTIONS AND RECOMMENDATIONS FOR THE SELECTION OF APPROPRIATE SURGICAL TECHNIQUE, IMPLANT SIZE AND CONFIGURATION, PRECAUTIONS THAT EXCESSIVE FORCE MAY CAUSE BREAKAGE OR DAMAGE TO THE DEVICE, AND THAT THE SURGEON SHOULD BE FAMILIAR WITH THE DEVICE AND THE TECHNIQUE PRIOR TO USE. THE INSTRUCTION FOR USE OF THE INSTRUMENT PACK STATES THAT THE INSTRUMENTS ARE NOT INTENDED TO BE IMPLANTED, AND PRECAUTIONS TO AVOID EXCESSIVE FORCE AS IT MAY DAMAGE THE INSTRUMENT. COMPANY CONTINUES TO MONITOR THESE EVENTS AS PART OF POST MARKET ACTIVITIES. ADDITIONAL REPORT FROM THE INITIAL IMPORTER RELATING TO THIS EVENT IS:

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE IN THE DISTAL FEMUR, A K-WIRE PROVIDED WITHIN THE CONVENIENCE KIT BROKE DURING INSERTION INSIDE THE PATIENT'S BONE. THE BROKEN PART WAS NOT RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749285 OSSIOFIBER TRIMMABLE FIXATION NAIL SYSTEM, CANNULATED ORTHOPEDIC TRAY OJH OSSIO LTD. OF2054070S OF05223 07290017630250

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown