BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON ROHS ANSPACH CONSOLE - 200030

    MDR report key: 9989222 · Received April 23, 2020

    Report

    Report Number
    3010266064-2020-00280
    Event Type
    Malfunction
    Date Received
    April 23, 2020
    Date of Event
    December 13, 2016
    Report Date
    August 11, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    HBE
    PMA / PMN Number
    K080802
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10 H3, H6: THE REPORTED DEVICE, USED FOR TREATMENT, WAS NOT MADE AVAILABLE TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION. THUS, VISUAL AND FUNCTIONAL INSPECTION WAS NOT PERFORMED.THERE WAS NO SERIAL NUMBER, LOT NUMBER, OR PART NUMBER NOTED IN THE INITIAL INVESTIGATION DOCUMENTS SO WE ARE UNABLE TO CONDUCT A DHR REVIEW AS A PART OF THE INVESTIGATION. A COMPLAINT HISTORY REVIEW IDENTIFIED SIMILAR EVENTS. THE NAVIO USER'S MANUAL FOR (TKA) USER'S MANUAL RELEASED AT THE TIME OF THE COMPLAINT PROVIDES DETAILED INSTRUCTIONS FOR USE OF THE ANSPACH SURGICAL DRILL CONSOLE AND FOOT PEDAL. THIS FAILURE IS AN IDENTIFIED FAILURE MODE IN THE RISK ASSESSMENT. THE ROOT CAUSE COULD NOT BE DETERMINED. FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT ARE RELATED TO A DETECTED FAILURE WITHIN THE ANSPACH CONSOLE WHICH IS REPORTED AS E2. THE E2 ERROR IS INFERRED BY THE CONSOLE FROM THE MOTOR CURRENT APPLIED AND THE RESULTING LACK OF MOTION WHEN THE COLLAR IS LOCKED. THE E2 ERROR IS CLEARED BY RELEASING THE LOCK AND ACTUATING THE FOOT CONTROL. NO REBOOT OR POWER CYCLE WAS REQUIRED TO RESTORE DRILL FUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TKA PROCEDURE, AN E2 ERROR OCCURRED DURING THE INITIAL BURRING PHASE OF THE FEMUR. THE BUR WAS RECONNECTED MULTIPLE TIMES, AS WELL AS UNPLUGGING AND REPLUGGING THE DRILL BACK IN. NEITHER OF THESE ATTEMPTS RESOLVED THE ISSUE. THE SURGEON DID NOT ALLOW REP TO RESTART THE SYSTEM, INSTEAD THE VISUALIZATION TOOL WAS USED AND PINNED THE JIGS IN PLACE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453147 NON ROHS ANSPACH CONSOLE - 200030 DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED HBE BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention