BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDPIECE, EMAX 2 PLUS (ANSPACH DRILL), ROHS COMPLIANT

    MDR report key: 9994194 · Received April 24, 2020

    Report

    Report Number
    3010266064-2020-00983
    Event Type
    Injury
    Date Received
    April 24, 2020
    Date of Event
    January 29, 2019
    Report Date
    August 13, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    HBE
    PMA / PMN Number
    K080802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE REPORTED DEVICE, USED FOR TREATMENT, WAS RETURNED FOR EVALUATION. THE RETURNED DRILL WAS PLUGGED INTO A SYSTEM WITH A KNOWN GOOD CONSOLE AND RUN THROUGH A DRILL TEST. THERE WERE NO ERRORS AND THE DRILL FUNCTIONED AS EXPECTED. THEN, THE DRILL WAS TESTED USING THE CONSOLE FROM THE ORIGINAL SYSTEM (CONSOLE WAS INVESTIGATED UNDER FR 19-0436) AND FUNCTIONED AS EXPECTED. THEN, THE DRILL WAS TESTED WITH THE DRILL EXTENSION CABLE (INVESTIGATED UNDER FR 19-0437) CONNECTED IN BETWEEN THE CONSOLE AND THE DRILL AND FUNCTIONED AS EXPECTED. THE OTHER 3 DRILLS THAT WERE USED WITH THE SYSTEM WERE ALSO TESTED IN THE SAME WAY (FR 19-0070, 19-0071, AND 19-0435) AND ALL FUNCTIONED AS EXPECTED. THEREFORE, THERE WAS NO PROBLEM FOUND WITH THE 4 DRILLS, CONSOLE AND EXTENSION CABLE. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. A COMPLAINT HISTORY REVIEW IDENTIFIED 5 PRIOR SIMILAR EVENTS. THIS FAILURE MODE WILL BE TRENDED TO ASSESS FOR ANY NECESSARY CORRECTIVE ACTIONS. THE SURGICAL SYSTEM USER'S MANUAL RELEASED AT THE TIME OF THE COMPLAINT (PN 500097 REV E) PROVIDES COMPLETE AND DETAILED INSTRUCTIONS FOR DRILL USAGE AND BUR CONTROL. THIS FAILURE MODE IS AN IDENTIFIED FAILURE IN THE RISK ASSESSMENT. WE WERE ABLE TO CONFIRM THERE WAS A RELATIONSHIP ESTABLISHED BETWEEN THE REPORTED EVENT AND THE DEVICE. SINCE IT WAS REPORTED THAT THE ERROR WAS STILL PRESENT AFTER UNPLUGGING AND PLUGGING THE DRILL BACK IN AND THAT THE ERROR WAS CLEARED BY REBOOTING THE SYSTEM AND NO PROBLEM WAS FOUND WITH THE RETURNED PARTS, THE MALFUNCTION IS LIKELY DUE TO THE E2 ERROR WHICH DOES NOT OCCUR WHEN THE DRILL IS JAMMED AND IS ONLY CLEAR BY REBOOTING THE ANSPACH CONSOLE. PER COMPLAINT DETAILS, THE DEVICE MALFUNCTIONED DURING USE AND THE NAVIO WAS ABANDONED FOR MANUAL INSTRUMENTATION. BASED ON THE INFORMATION PROVIDED THE MODIFIED PROCEDURE DID NOT RESULT IN PATIENT INJURY/IMPACT; THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TKA PROCEDURE THE DRILL WAS NOT WORKING. THE NAVIO CASE WAS ABORTED AND CONVERTED TO A MANUAL INSTRUMENTATION UNTIL THE SYSTEM WAS PROPERLY RESTARTED. INVESTIGATION RESULTS SHOWED THAT THERE WAS NO PROBLEM FOUND WITH THE DRILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459988 HANDPIECE, EMAX 2 PLUS (ANSPACH DRILL), ROHS COMPLIANT DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1