BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSSIOFIBER THREADED TRIMMABLE FIXATION NAIL SYSTEM, F/A 4.5X70MM

    MDR report key: 20818033 · Received December 2, 2024

    Report

    Report Number
    3014554088-2024-00012
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    November 4, 2024
    Report Date
    December 2, 2024
    Manufacturer
    OSSIO LTD.
    Product Code
    OJH
    UDI-DI
    07290019361091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPANY WAS INFORMED OF AN INSERTER BREAKING INSIDE AN IMPLANT NEAR ITS FINAL POSITION IN BONE. SURGEON WAS SATISFIED WITH THE FINAL STRUCTURE RESULT, BUT COULD NOT RETRIEVE THE BROKEN INSERTER 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 (IMPLANT AND INSERTER). IT WAS CONCLUDED THAT THIS EVENT WAS THE OUTCOME OF AN UNINTENDED USE ERROR OF THE DEVICE, WHICH RESULTED IN EXCESSIVE TORSIONAL FORCES LEADING TO THE INSERTER BREAKAGE. THE INSTRUCTIONS FOR USE OF THE IMPLANT INCLUDE PRECAUTIONS AND RECOMMENDATIONS FOR THE SELECTION OF APPROPRIATE SURGICAL TECHNIQUE, IMPLANT SIZE AND CONFIGURATION AND PRECAUTION THAT EXCESSIVE FORCE MAY CAUSE BREAKAGE OR DAMAGE TO THE DEVICE. 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: #3014323288-2024-00012.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRI-MALLEOLAR FRACTURE FIXATION PROCEDURE THE INSERTER PROVIDED WITHIN THE CONVENIENCE KIT HAD BROKEN INSIDE THE IMPLANT DURING INSERTION. THE BROKEN PART WAS NOT RETRIEVED. THE SURGERY WAS COMPLETED WITH NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97828 OSSIOFIBER THREADED TRIMMABLE FIXATION NAIL SYSTEM, F/A 4.5X70MM ORTHOPEDIC TRAY OJH OSSIO LTD. OF2084520S OF04779 07290019361091

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female SYNDESMOSIS TIGHTROPE XP IMPLANT, TITANIUM| TWO OSSIOFIBER TTF NAIL SYSTEM, 4.5X70