REAL INTELLIGENCE ROBOTIC DRILL
Report
- Report Number
- 3010266064-2022-00068
- Event Type
- Injury
- Date Received
- February 2, 2022
- Date of Event
- January 13, 2022
- Report Date
- January 10, 2024
- Manufacturer
- BLUE BELT TECHNOLOGIES
- Product Code
- OLO
- UDI-DI
- 00885556757321
- PMA / PMN Number
- K201022
- Removal / Correction Number
- RES# 93620
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INTERNAL COMPLAINT REFERENCE: (B)(4).
ADDITIONAL DATA: H6 CORRECTED DATA: B5.
H3, H6: THE REAL INTELLIGENCE ROBOTIC DRILL, P/N: ROB10013, (B)(6), INTENDED FOR USE IN TREATMENT WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE WAS ESTABLISHED. NOTHING WAS IDENTIFIED VISUALLY THAT CONTRIBUTED TO THE REPORTED PROBLEM. A FUNCTIONAL EVALUATION WAS PERFORMED. THE REPORTED PROBLEM WAS CONFIRMED. A KPC TEST WAS RUN UNSUCCESSFULLY. THE DRILL DISPLAYED A CRITICAL ERROR DURING TESTING. A CASE WAS RUN, AND THE DRILL DISPLAYED A TIMEOUT ERROR FOLLOWED BY A DRILL FLICKER ICON AT THE CONNECTION SCREEN. THE MOST LIKELY CAUSE OF THIS EVENT IS THE DRILL EXPOSURE MOTOR ENCODER IS FAILING TO COMMUNICATE WITH THE SYSTEM CONSOLE. A REVIEW OF MANUFACTURING AND SERVICE RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS HAS IDENTIFIED PRIOR EVENTS. A HISTORICAL ESCALATION EVENT REVIEW WAS COMPLETED. THE REVIEW DETERMINED THAT PRIOR ESCALATION ACTIONS ARE APPLICABLE TO THE SCOPE OF THIS COMPLAINT AND FURTHER INVESTIGATION INTO THE REPORTED FAILURE IS BEING CONDUCTED TO DETERMINE IF ADDITIONAL ESCALATION ACTIONS ARE REQUIRED. REFER TO CORI USER MANUAL FOR GUIDELINES FOR RECOVERING TO A FULLY MANUAL PROCEDURE. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THE DOCUMENTED RISK LEVEL IS STILL ADEQUATE. PER COMPLAINT DETAILS FROM THE US, IT WAS REPORTED THAT DURING SET UP FOR A CORI ASSISTED TKA SURGERY THEY RECEIVED A "SYSTEM TIME OUT" ERROR WHEN THE ROBOTIC DRILL WAS PLUGGED IN. THEY TRIED A SECOND ROBOTIC DRILL, AND WERE MET WITH THE SAME ERROR. AFTER GETTING THE SYSTEM TIME OUT ERROR WITH THE SECOND REAL INTELLIGENCE ROBOTIC DRILL, THEY TRIED TO DO A DRILL DIAGNOSTICS TEST ON THIS SECOND DRILL, AND HAD A ROBOTIC DRILL CRITICAL ERROR AND WERE UNABLE TO CONTINUE WITH THE TEST. THE WHITE LIGHT ABOVE THE CONNECTION PORT WAS CONSTANTLY BLINKING WITH THE SECOND REAL INTELLIGENCE ROBOTIC DRILL. THE CASE WAS ABORTED AND PROCEDURE WAS COMPLETED WITHOUT DELAY BY CHANGING TO MANUAL INSTRUMENTS. FURTHER INVESTIGATION INTO THE REPORTED FAILURE IS BEING CONDUCTED TO DETERMINE IF ADDITIONAL ACTIONS ARE REQUIRED. THE FAILURE MODE WILL CONTINUE TO BE CLOSELY MONITORED THROUGH COMPLAINT INVESTIGATION AND TRENDED THROUGH POST MARKET SURVEILLANCE ACTIVITIES.
H3, H6: THE REAL INTELLIGENCE ROBOTIC DRILL, P/N ROB10013, SN000926, INTENDED FOR USE IN TREATMENT WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE WAS ESTABLISHED. NOTHING WAS IDENTIFIED VISUALLY THAT CONTRIBUTED TO THE REPORTED PROBLEM. A FUNCTIONAL EVALUATION WAS PERFORMED. THE REPORTED PROBLEM WAS CONFIRMED. A KPC TEST WAS RUN UNSUCCESSFULLY. THE DRILL DISPLAYED A CRITICAL ERROR DURING TESTING. A CASE WAS RUN, AND THE DRILL DISPLAYED A TIMEOUT ERROR FOLLOWED BY A DRILL FLICKER ICON AT THE CONNECTION SCREEN. THE MOST LIKELY CAUSE OF THIS EVENT IS ASSOCIATED WITH A FAILURE OF THE DRILL EXPOSURE MOTOR DUE TO THE THERMO-MECHANICAL STRESS INDUCED WITHIN THE MOTOR AT THE ENCODER AND ELECTRICAL NOISE ON THE CONSOLE ERROR STATUS INPUTS TO THE DRILL EXPOSURE MOTOR ENCODER. A REVIEW OF MANUFACTURING AND SERVICE RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS HAS IDENTIFIED PRIOR EVENTS. WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. A HISTORICAL REVIEW CONCLUDED THAT THE LOT, SERIAL NUMBER OR PART NUMBER REPORTED IN THIS EVENT IS RELATED TO A CORRECTIVE/PREVENTIVE ACTION ALREADY IMPLEMENTED. REFER TO CORI USER MANUAL FOR GUIDELINES FOR RECOVERING TO A FULLY MANUAL PROCEDURE. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THE DOCUMENTED RISK LEVEL IS STILL ADEQUATE. CONTINUOUS IMPROVEMENTS HAVE BEEN MADE TO THE CORI ROBOTIC DRILL AND MANUFACTURING PROCESSES TO REDUCE DRILL DISCONNECTION ERROR MESSAGES. THESE IMPROVEMENTS CONSISTED OF: 1. A HARDWARE UPDATE TO THE CORI CONSOLE TO REDUCE NOISE ON THE INTERNAL ELECTRONICS. 2. AN UPDATE TO THE CORI SYSTEM¿S SOFTWARE AND FIRMWARE TO IMPROVE THE USER EXPERIENCE WHEN ERROR MESSAGES ARE DISPLAYED, AND 3. A HARDWARE UPDATE TO THE CORI DRILL TO REDUCE MECHANICAL STRESS ON DRILL EXPOSURE THE MOTOR. THE FIRST TWO IMPROVEMENTS ARE FULLY DEPLOYED. THE THIRD IMPROVEMENT IS BEING DEPLOYED FOR NEW ORDERS AND AS DRILLS ARE RETURNED FOR ROUTINE SERVICING. ALSO, SMITH+NEPHEW IS VOLUNTARILY PERFORMING A RECALL/FIELD NOTIFICATION FOR THE CORI REAL INTELLIGENCE ROBOTIC DRILL. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED THE COMPLAINT WILL BE REOPENED. THE FAILURE MODE WILL CONTINUE TO BE CLOSELY MONITORED THROUGH COMPLAINT INVESTIGATION AND TRENDED THROUGH POST MARKET SURVEILLANCE ACTIVITIES.
H3, H6: THE REAL INTELLIGENCE ROBOTIC DRILL, P/N ROB10013, (B)(6), INTENDED FOR USED IN TREATMENT, WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE WAS ESTABLISHED. A FUNCTIONAL EVALUATION WAS PERFORMED. THE REPORTED PROBLEM WAS FUNCTIONALITY CONFIRMED. A KPC TEST WAS TRY TO BE RUN UNSUCCESSFULLY. THE DRILL THROWS A CRITICAL ERROR DURING TESTING. A CASE WAS RUN, AND THE DRILL THROWS A TIMEOUT ERROR FOLLOWED BY A DRILL FLICKER ICON AT THE CONNECTION SCREEN. A REVIEW OF MANUFACTURING AND SERVICE RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS HAS IDENTIFIED PRIOR EVENTS. A HISTORICAL ESCALATION EVENT REVIEW WAS COMPLETED. THE REVIEW DETERMINED THAT PRIOR ESCALATION ACTIONS ARE APPLICABLE TO THE SCOPE OF THIS COMPLAINT HOWEVER NO FURTHER ESCALATION ACTION IS REQUIRED. THE MOST LIKELY CAUSE OF THIS EVENT WAS THAT THE DRILL EXPOSURE MOTOR ENCODER IS FAILING TO COMMUNICATE WITH THE SYSTEM CONSOLE. REFER TO CORI USER MANUAL APPENDIX D: RECOVERY PROCEDURE GUIDELINES FOR GUIDELINES FOR RECOVERING TO A FULLY MANUAL PROCEDURE. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THE DOCUMENTED RISK LEVEL IS STILL ADEQUATE. ALTHOUGH NO FURTHER CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME, ALL COMPLAINTS ARE MONITORED THROUGH COMPLAINT INVESTIGATION AND POST MARKET SURVEILLANCE ACTIVITIES. ADDITIONAL INFORMATION: D8/D9.
IT WAS REPORTED THAT DURING SET UP FOR A CORI ASSISTED TKA SURGERY THEY RECEIVED A "SYSTEM TIME OUT" ERROR WHEN THE FIRST ROBOTIC DRILL WAS PLUGGED IN. THEY TRIED A SECOND ROBOTIC DRILL, AND WERE MET WITH THE SAME ERROR. THEY HAD USED THE SAME DRILL ATTACHMENT FOR BOTH HANDPIECES. AFTER GETTING THE SYSTEM TIME OUT ERROR WITH THE SECOND REAL INTELLIGENCE ROBOTIC DRILL, THEY TRIED TO DO A DRILL DIAGNOSTICS TEST ON THIS SECOND DRILL, AND HAD A ROBOTIC DRILL CRITICAL ERROR AND WERE UNABLE TO CONTINUE WITH THE TEST. THE RI ROBOTIC DRILL ATTACHMENT WAS ALSO LOCKED ONTO THE DRILL AND WILL NOT COME OFF EVEN WITH TRYING TO UNLOCK THROUGH THE DRILL DIAGNOSTICS TEST. THE WHITE LIGHT ABOVE THE CONNECTION PORT WAS CONSTANTLY BLINKING WITH THE SECOND REAL INTELLIGENCE ROBOTIC DRILL. THE CASE WAS ABORTED AND PROCEDURE WAS COMPLETED WITHOUT DELAY BY CHANGING TO MANUAL INSTRUMENTS. AFTER THE SURGERY, THEY RETRIED THE SET UP WITH THE FIRST ROBOTIC DRILL AND A DIFFERENT LONG ATTACHMENT, AND IT FUNCTIONED CORRECTLY - THEY WERE ABLE TO PROCEED PAST THE UNLOCKING SCREEN.
IT WAS REPORTED THAT DURING SET UP FOR A CORI ASSISTED TKA SURGERY THEY RECEIVED A "SYSTEM TIME OUT" ERROR WHEN THE FIRST ROBOTIC DRILL WAS PLUGGED IN. THEY TRIED A SECOND ROBOTIC DRILL, AND WERE MET WITH THE SAME ERROR. THEY HAD USED THE SAME DRILL ATTACHMENT FOR BOTH HANDPIECES. AFTER GETTING THE SYSTEM TIME OUT ERROR WITH THE SECOND REAL INTELLIGENCE ROBOTIC DRILL, THEY TRIED TO DO A DRILL DIAGNOSTICS TEST ON THIS SECOND DRILL, AND HAD A ROBOTIC DRILL CRITICAL ERROR AND WERE UNABLE TO CONTINUE WITH THE TEST. THE RI ROBOTIC DRILL ATTACHMENT WAS ALSO LOCKED ONTO THE DRILL AND WILL NOT COME OFF EVEN WITH TRYING TO UNLOCK THROUGH THE DRILL DIAGNOSTICS TEST. THE WHITE LIGHT ABOVE THE CONNECTION PORT WAS CONSTANTLY BLINKING WITH THE SECOND REAL INTELLIGENCE ROBOTIC DRILL. THE CASE WAS ABORTED AND PROCEDURE WAS COMPLETED WITHOUT DELAY BY CHANGING TO MANUAL INSTRUMENTS. AFTER THE SURGERY, THEY RETRIED THE SET UP WITH THE FIRST ROBOTIC DRILL AND A DIFFERENT LONG ATTACHMENT, AND IT FUNCTIONED CORRECTLY - THEY WERE ABLE TO PROCEED PAST THE UNLOCKING SCREEN. ACCORDING TO THE INVESTIGATION, THE DRILL EXPOSURE MOTOR ENCODER IS FAILING TO COMMUNICATE WITH THE SYSTEM CONSOLE.
IT WAS REPORTED THAT DURING SET UP FOR A CORI ASSISTED TKA SURGERY THEY RECEIVED A "SYSTEM TIME OUT" ERROR WHEN THE FIRST ROBOTIC DRILL WAS PLUGGED IN. THEY TRIED A SECOND ROBOTIC DRILL, AND WERE MET WITH THE SAME ERROR. THEY HAD USED THE SAME DRILL ATTACHMENT FOR BOTH HANDPIECES. AFTER GETTING THE SYSTEM TIME OUT ERROR WITH THE SECOND REAL INTELLIGENCE ROBOTIC DRILL, THEY TRIED TO DO A DRILL DIAGNOSTICS TEST ON THIS SECOND DRILL, AND HAD A ROBOTIC DRILL CRITICAL ERROR AND WERE UNABLE TO CONTINUE WITH THE TEST. THE RI ROBOTIC DRILL ATTACHMENT WAS ALSO LOCKED ONTO THE DRILL AND WILL NOT COME OFF EVEN WITH TRYING TO UNLOCK THROUGH THE DRILL DIAGNOSTICS TEST. THE WHITE LIGHT ABOVE THE CONNECTION PORT WAS CONSTANTLY BLINKING WITH THE SECOND REAL INTELLIGENCE ROBOTIC DRILL. THE CASE WAS ABORTED AND PROCEDURE WAS COMPLETED WITHOUT DELAY BY CHANGING TO MANUAL INSTRUMENTS. AFTER THE SURGERY, THEY RETRIED THE SET UP WITH THE FIRST ROBOTIC DRILL AND A DIFFERENT LONG ATTACHMENT, AND IT FUNCTIONED CORRECTLY - THEY WERE ABLE TO PROCEED PAST THE UNLOCKING SCREEN. ACCORDING TO THE INVESTIGATION, THE DRILL EXPOSURE MOTOR ENCODER IS FAILING TO COMMUNICATE WITH THE SYSTEM CONSOLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102384 | REAL INTELLIGENCE ROBOTIC DRILL | ORTHOPEDIC STEREOTAXIC INSTRUMENT | OLO | BLUE BELT TECHNOLOGIES | ROB10013 | 00885556757321 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |