BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT

    MDR report key: 9996094 · Received April 24, 2020

    Report

    Report Number
    3010266064-2020-00681
    Event Type
    Injury
    Date Received
    April 24, 2020
    Date of Event
    July 20, 2018
    Report Date
    August 18, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    PMA / PMN Number
    K191223
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE DEVICE WAS USED DURING TREATMENT BUT WAS NOT RETURNED FOR EVALUATION. THE LOG FILES WERE RETURNED FOR REVIEW AND INDICATED THAT A JAM DETECTION OCCURRED. THE DHR WAS REVIEWED AND FOUND THAT THE DEVICE MET THE MANUFACTURING SPECIFICATIONS. A COMPLAINT HISTORY REVIEW FOUND SIMILAR COMPLAINTS OF THE REPORTED ISSUE AND WILL CONTINUE TO BE MONITORED. THE SURGICAL TECHNIQUE GUIDE RELEASED AT THE TIME OF THE COMPLAINT PROVIDES A WARNING STATEMENT ON WHAT TO DO WHEN THERE IS A HOMING FAILURE. IT STATES "REASONS FOR FAILURE COULD INCLUDE THE FOLLOWING: HANDPIECE NOT IN POINT PROBE OR JAMMED OR DRILL HAS MISSING OR POORLY INSTALLED BUR. PRESS "DISMISS AND RE-HOME THE HANDPIECE. REPEAT THE HOMING PROCESS SEVERAL TIMES AS NECESSARY UNTIL HOMING SUCCEEDS. YOU MUST SUCCESSFULLY HOME THE HANDPIECE BEFORE YOU PROCEED. IF HOMING FAILS REPEATEDLY, TRY USING A NEW BUR. IF HOMING STILL FAILS, TRY USING A NEW HANDPIECE.". THIS FAILURE IS AN IDENTIFIED FAILURE MODE WITHIN THE RISK FILE. THE RELATIONSHIP OF THE DEVICE AND THE REPORTED EVENT HAS BEEN ESTABLISHED. THE LOG FILE INDICATED THAT A JAM DETECTION ERROR HAD OCCURRED, WHICH ONLY OCCURS WHEN THE BUR COMES IN CONTACT WITH THE PLATE OF THE POINT PROBE PRIOR TO REACHING FULL EXPOSURE. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT WAS DUE TO USER ERROR. PER COMPLAINT DETAILS, THE DEVICE MALFUNCTIONED DURING USE. BASED ON THE INFORMATION PROVIDED, AS THE USER ABORTED THE PROCEDURE AND CHANGED TO MANUAL INSTRUMENTATION; THERE WAS NO SURGICAL DELAY OR PATIENT INJURY/IMPACT REPORTED. 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 CUSTOMER WAS CHANGING BURR TO 5MM SPHERICAL AND ERROR MESSAGE "HAND PIECE EXPOSURE CONTROL ERROR" APPEARED. NORMAL TROUBLESHOOTING WAS PERFORMED AND BURR WAS CHECKED FOR THE CORRECT SIZE. NEW HAND PIECE WAS CHANGED AND A 2MM BURR USED TO BURR HOLES IN THE DISTAL FEMUR WHICH HOMED (THIS WAS DONE WHILST IT WAS DOUBLE CONFIRMED THAT WE HAD A 5MM SPHERICAL BURR). THE CUSTOMER CHANGED TO A 5MM SPHERICAL BURR ON THE NEW HAND-PIECE AND THE SAME ERROR APPEARED (TIBIA WAS CONVERTED TO STANDARD INSTRUMENTATION). WE TRIED TO CALIBRATE AND HOME MULTIPLE TIMES. FOLLOWING THE CASE, THE HANDPIECES WERE RETESTED ON THE UNIT WITH THE ORIGINAL CASE STILL OPEN ON THE SYSTEM. FIRSTLY THE HANDPIECE AND 5MM SPHERICAL BURR CALIBRATED/HOMED FINE, WE THEN CHANGED THE HANDPIECE OVER AGAIN THE SAME ERROR APPEARED. AFTER REPEATING THIS THEN HAPPENED TO BOTH HANDPIECES AND THE WOULD NOT HOME WITH THE SAME ERROR OCCURRING. NO PATIENT INJURIES REPORTED BEYOND THIS EVENT. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THE DEVICES WERE NOT RETURNED, HOWEVER, UPON REVIEW OF THE LOG FILES, IT WAS DETERMINED THAT THE ERRORS WERE JAM DETECTION ERRORS CAUSED BY USER ERROR. THE JAM DETECTION ERRORS ARE INDICATIVE OF ENTERING CUT MODE WHILE IN SPEED CONTROL AND WITH THE HANDPIECE STILL CONNECTED TO THE POINT PROBE, WHEN THE HANDPIECE TRIES TO EXTEND THE BUR TO ITS FULL EXPOSURE, THE BUR COMES INTO CONTACT WITH THE PLATE AT THE POINT PROBE PRIOR TO REACHING FULL EXPOSURE AND THUS THROWING JAM DETECTION ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462098 HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention