BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISWISS HIP NAVIGATION SYSTEM

    MDR report key: 20864448 · Received December 6, 2024

    Report

    Report Number
    3017123055-2024-00001
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    October 24, 2022
    Report Date
    November 13, 2023
    Manufacturer
    NAVISWISS AG
    Product Code
    OLO
    PMA / PMN Number
    K193094
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER A THOROUGH REVIEW OF THE EQUIPMENT AND PROCEDURAL ASPECTS AT THE HOSPITAL AND GIVEN THE ISOLATED AND CLUSTERED OCCURRENCE OF THESE INFECTIONS, IT IS SUREGONS OPINION THAT THESE INFECTIONS WERE UNRELATED TO THE NAVISWISS TECHNOLOGY. RATHER, IT APPEARS TO BE A RESULT OF BASIC PROCEDURAL ISSUES WITHIN THE RE-PROCESSING DEPARTMENT, WHICH HAVE NOW BEEN RECTIFIED THROUGH ADDITIONAL TRAINING MEASURES. THESE TRAINING MEASURES WERE CARRIED OUT ON (B)(6)2023 AND INCLUDED A THOROUGH REVIEW OF BASIC HYGIENIC PROCESSES AND THE WELL DESCRIBED NAVISWISS RE-PROCESSING INSTRUCTIONS. FOLLOWING THIS INITIATIVE, THE ISSUE HAS NOT RECURRED. AGAIN, IT IS SURGEON OPINION THAT THESE 3X CASES OF POST-OPERATIVE INFECTION WERE UNRELATED TO THE NAVISWISS PLATFORM. PRODUCT WAS NOT RETURNED FOR INVESTIGATION. NAVISWISS REPORTED THE THREE CASES IN ONE REPORT (SEE: MDR 3017123055-2023-00001). NAVISWISS ADMITS THAT AT THE TIME OF REPORTING THE EVENT, IT WAS NOT AWARE THAT A SEPARATE REPORT WAS REQUIRED FOR EACH EVENT IN A SERIES OF REPORTABLE MDR EVENTS, AS REQUIRED BY THE FDA GUIDANCE DOCUMENT "MEDICAL DEVICE REPORTING FOR MANUFACTURERS, GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF". THE CURRENT REPORT IS INTENDED TO REMEDY THE OMISSION OF NOT HAVING SUBMITTED A SEPARATE MDR REPORT FOR EACH EVENT AND REFERS TO THE SECOND CASE. IN RESPONSE TO THE INCIDENT REPORTED, NAVISWISS HAS TAKEN DECISIVE STEPS TO STRENGTHEN THEIR REPORTING AND STERILIZATION PROCESSES, ENSURING SUCH AN OCCURRENCE IS RIGOROUSLY PREVENTED IN THE FUTURE. THE IMPLEMENTATION OF UPDATED PROCEDURES AND THE CREATION OF A NEW STERILIZATION PROCESS REFLECT NAVISWISS'S COMMITMENT TO PATIENT SAFETY AND QUALITY ASSURANCE. THESE ACTIONS DEMONSTRATE NAVISWISS'S RESOLVE TO MAINTAIN THE HIGHEST STANDARDS AND REINFORCE OUR DEDICATION TO THE WELL-BEING OF OUR PATIENTS.

    Description of Event or Problem · 0

    A SURGEON PERFORMED A REVIEW OF HIS MOST RECENT 118 TOTAL HIP ARTHROPLASTY (THA) CASES THAT INVOLVED THE USE OF THE NAVISWISS TECHNOLOGY. THIS REVIEW WAS TRIGGERED BY THE INCIDENCE OF 3 OUT OF 118 CASES PRESENTING WITH POST-OPERATIVE INFECTION THAT REQUIRED ONGOING MANAGEMENT. THE SINGLE INCIDENTS OCCURED IN (B)(6) 2022 AND WERE NOT REPORTED AS SINGLE INCIDENTS TO NAVISWISS. IN (B)(6) 2023 NAVISWISS WAS INFORMED REGARDING THE SITUATION. NO ALLEGATION WAS MADE AGAINST THE MEDICAL DEVICE, FURTHERMORE THE SUREGEON LOCATED THE ROOT CAUSE IN THE IN-HOUSE REPROCESSING PROCESS (NON-COMPLIANCE). SEE ALSO SECTION B7. NAVISWISS REPORTED THE THREE CASES IN ONE REPORT (SEE: MDR 3017123055-2023-00001). NAVISWISS ADMITS THAT AT THE TIME OF REPORTING THE EVENT, IT WAS NOT AWARE THAT A SEPARATE REPORT WAS REQUIRED FOR EACH EVENT IN A SERIES OF REPORTABLE MDR EVENTS, AS REQUIRED BY THE FDA GUIDANCE DOCUMENT "MEDICAL DEVICE REPORTING FOR MANUFACTURERS, GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF". THE CURRENT REPORT IS INTENDED TO REMEDY THE OMISSION OF NOT HAVING SUBMITTED A SEPARATE MDR REPORT FOR EACH EVENT AND REFERS TO THE SECOND CASE. IN RESPONSE TO THE INCIDENT REPORTED, NAVISWISS HAS TAKEN DECISIVE STEPS TO STRENGTHEN THEIR REPORTING AND STERILIZATION PROCESSES, ENSURING SUCH AN OCCURRENCE IS RIGOROUSLY PREVENTED IN THE FUTURE. THE IMPLEMENTATION OF UPDATED PROCEDURES AND THE CREATION OF A NEW STERILIZATION PROCESS REFLECT NAVISWISS'S COMMITMENT TO PATIENT SAFETY AND QUALITY ASSURANCE. THESE ACTIONS DEMONSTRATE NAVISWISS'S RESOLVE TO MAINTAIN THE HIGHEST STANDARDS AND REINFORCE OUR DEDICATION TO THE WELL-BEING OF OUR PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2489666 NAVISWISS HIP NAVIGATION SYSTEM NAVISWISS HIP NAVIGATION SYSTEM OLO NAVISWISS AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other