BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANSPACH EMAX 2 PLUS HAND PIECE - ROHS

    MDR report key: 10875181 · Received November 20, 2020

    Report

    Report Number
    3010266064-2020-02019
    Event Type
    Injury
    Date Received
    November 20, 2020
    Date of Event
    November 2, 2020
    Report Date
    May 19, 2021
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    PMA / PMN Number
    K191223
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE (PN: 101092, SN: (B)(6), USED IN TREATMENT, WAS RETURNED FOR INVESTIGATION. DHR REVIEW FOUND THAT NO CONDITIONS THAT COULD CONTRIBUTE TO THE REPORTED EVENT WERE FOUND. THE REPORTED PRODUCT MET MANUFACTURING SPECIFICATIONS PRIOR TO BEING RELEASED FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTS, THIS ISSUE WILL CONTINUE TO BE MONITORED. THIS FAILURE MODE IS IDENTIFIED IN THE RISK PROFILE. THE NAVIO USER'S MANUAL (500196) NAVIO SURGICAL TECHNIQUE GUIDE (500197) PROVIDE INSTRUCTIONS FOR DRILL SETUP FOR THE BUR, TROUBLESHOOTING, AND USAGE. WE WERE ABLE TO CONFIRM IF THERE WAS A RELATIONSHIP ESTABLISHED BETWEEN THE REPORTED EVENT AND THE DEVICE. THE REPORTED PROBLEM WAS NOT CONFIRMED VISUALLY, BUT FUNCTIONAL EVALUATION FOUND THAT THE WHEN A BUR WAS INSERTED INTO THE DEVICE, THE BUR WOULD UNSEAT IN THE LOCKING MECHANISM AND DISENGAGE. THIS IS INDICATIVE OF DAMAGE TO THE LOCKING MECHANISM, WHICH IS TYPICALLY CAUSED BY WEAR OVER TIME. BASED ON THE INVESTIGATION, NO CORRECTIONS OR CORRECTIVE ACTIONS REQUIRED AT THIS TIME. THE MEDICAL EVALUATION FOUND THAT PER COMPLAINT DETAILS, THE DEVICE (ANSPACH DRILL/BUR) MALFUNCTIONED DURING BONE REMOVAL OF A UKR. IT WAS COMMUNICATED THAT THE NAVIO¿ WAS ABANDONED AND THE SURGERY WAS COMPLETED USING CONVENTIONAL INSTRUMENTS WITH A DELAY OF APPROXIMATELY 15 MINUTES. PER THE FIELD REPORT, NO PATIENT HARM OR ADDITIONAL COMPLICATIONS WERE REPORTED. BASED ON THIS INFORMATION, PATIENT IMPACT BEYOND THE REPORTED MODIFIED PROCEDURE AND THE 15-MINUTE SURGICAL DELAY WOULD NOT BE ANTICIPATED AS THE CASE WAS REPORTEDLY COMPLETED WITH CONVENTIONAL INSTRUMENTATION. NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING BONE REMOVAL IN A NAVIO UKR PROCEDURE, THE ANSPACH DRILL WAS NOT ABLE TO RETAIN THE BUR INTO THE CHUCK. THE SURGERY WAS CONVERTED TO MANUAL PROCEDURE WITH A DELAY OF 15 MINUTES. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341430 ANSPACH EMAX 2 PLUS HAND PIECE - ROHS ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention