NAVIO SURGICAL SYSTEM US

Report

Report Number: 3010266064-2020-01745
Event Type: Injury
Date Received: September 1, 2020
Date of Event: August 6, 2020
Report Date: March 25, 2022
Manufacturer: BLUE BELT TECHNOLOGIES
Product Code: OLO
UDI-DI: 00885556628416
PMA / PMN Number: K191223
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

H3, H6: THE NAVIO SURGICAL SYSTEM CPU (US)200509, S/N (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. THE CPU WOULD ATTEMPT TO BOOT BUT NO VIDEO WAS PRESENT. ADDITIONAL TROUBLESHOOTING DETERMINED THAT THE HARD DRIVE WAS CORRUPT AND THE SYSTEM WILL NO LONGER BOOT TO THE NAVIO APPLICATION. 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 FOUND SIMILAR EVENTS. THE MOST LIKELY CAUSE OF THIS EVENT IS MECHANICAL FAILURE OF THE HARD DRIVE. SINCE THE HARD DRIVE IS AN OEM PRODUCT, THE ROOT CAUSE COULD NOT BE DETERMINED. A HISTORICAL ESCALATION EVENT REVIEW WAS COMPLETED. A REVIEW OF PRIOR ESCALATION ACTIONS FOUND NO ACTIONS APPLICABLE TO THE SCOPE OF THIS CASE. IF A NAVIO SURGICAL SYSTEM FAILURE OCCURS AT ANY POINT DURING THE SURGICAL CASE, THE SURGICAL TECHNIQUE GUIDE PROVIDES A ¿RECOVERY PROCEDURE GUIDELINES¿ TABLE 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. THIS COMPLAINT FROM THE UNITED STATES REPORTS THAT THE NAVIO SYSTEM WOULD NOT BOOT UP. IT WAS DETERMINED THAT THE HARD DRIVES WERE CORRUPTED AND NEEDED REPLACEMENT. THE UNIT FAILED BEFORE THE SURGERY STARTED, SO THE SURGEON COMPLETED THE SURGERY WITH MANUAL INSTRUMENTATION. THE NAVIO WAS NEVER USED ON THE PATIENT, SO THERE WAS NO IMPACT TO THE PATIENT'S HEALTH OR TO THE OUTCOMES OF THE SURGERY. SMITH + NEPHEW HAS NOT RECEIVED ADEQUATE MATERIALS (OPERATIVE REPORTS) TO FULLY EVALUATE THE COMPLAINT, BUT IF ADDITIONAL CLINICALLY RELEVANT MATERIALS ARE LATER RECEIVED, THEN THE CASE MAY BE RE-OPENED FOR FURTHER EVALUATION. ALTHOUGH NO FURTHER CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME, ALL COMPLAINTS ARE MONITORED AND TRENDED THROUGH POST MARKET SURVEILLANCE ACTIVITIES.

Additional Manufacturer Narrative · 0

H3, H6: THE NAVIO SURGICAL SYSTEM CPU (US)200509, S/N (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. THE CPU WOULD ATTEMPT TO BOOT BUT NO VIDEO WAS PRESENT. ADDITIONAL TROUBLESHOOTING DETERMINED THAT THE HARD DRIVE WAS CORRUPT AND THE SYSTEM WILL NO LONGER BOOT TO THE NAVIO APPLICATION. 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 FOUND SIMILAR EVENTS. THE MOST LIKELY CAUSE OF THIS EVENT IS MECHANICAL FAILURE OF THE HARD DRIVE. SINCE THE HARD DRIVE IS AN OEM PRODUCT, THE ROOT CAUSE COULD NOT BE DETERMINED. A HISTORICAL ESCALATION EVENT REVIEW WAS COMPLETED. A REVIEW OF PRIOR ESCALATION ACTIONS FOUND NO ACTIONS APPLICABLE TO THE SCOPE OF THIS CASE. IF A NAVIO SURGICAL SYSTEM FAILURE OCCURS AT ANY POINT DURING THE SURGICAL CASE, THE SURGICAL TECHNIQUE GUIDE PROVIDES A ¿RECOVERY PROCEDURE GUIDELINES¿ TABLE 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. THIS COMPLAINT FROM THE UNITED STATES REPORTS THAT THE NAVIO SYSTEM WOULD NOT BOOT UP. IT WAS DETERMINED THAT THE HARD DRIVES WERE CORRUPTED AND NEEDED REPLACEMENT. THE UNIT FAILED BEFORE THE SURGERY STARTED, SO THE SURGEON COMPLETED THE SURGERY WITH MANUAL INSTRUMENTATION. THE NAVIO WAS NEVER USED ON THE PATIENT, SO THERE WAS NO IMPACT TO THE PATIENT'S HEALTH OR TO THE OUTCOMES OF THE SURGERY. SMITH + NEPHEW HAS NOT RECEIVED ADEQUATE MATERIALS (OPERATIVE REPORTS) TO FULLY EVALUATE THE COMPLAINT, BUT IF ADDITIONAL CLINICALLY RELEVANT MATERIALS ARE LATER RECEIVED, THEN THE CASE MAY BE RE-OPENED FOR FURTHER EVALUATION. ALTHOUGH NO FURTHER CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME, ALL COMPLAINTS ARE MONITORED AND TRENDED THROUGH POST MARKET SURVEILLANCE ACTIVITIES.

Description of Event or Problem · 1

IT WAS REPORTED THAT, BEFORE A NAVIO PROCEDURE, IT WAS NOTICED THAT THE UPS SWITCH IN THE BACK OF THE CART WAS TURNED OFF. THEY FLIPPED IT ON AND THEN TURNED ON THE NAVIO SYSTEM, BUT "AN ERROR OCCURRED DURING INITIALIZATION" APPEARED. IT LOOKED LIKE THE HARD DRIVES NEEDED TO SYNC UP AND THEY LOGGED INTO BLUEBELT ADMIN, AND RAN THE COMMAND TO CHECK THE STATUS OF THE RE-SYNC. AFTER THE SYSTEM WAS DONE RE-SYNCING, IT WAS REBOOTED. HOWEVER, THE SCREEN GOT STUCK ON VARIOUS COMMANDS. THE "CTRL+ALT+F2" COMMAND COULD NOT BE USED ANYMORE TO LOG INTO BLUEBELT ADMIN. THE HARD DRIVES WERE CORRUPTED AND REQUIRES TO BE REPLACED. THE PROCEDURE WAS CONTINUED WITH MANUAL INSTRUMENTS. NO OTHER COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
943987	NAVIO SURGICAL SYSTEM US	ORTHOPEDIC STEREOTAXIC INSTRUMENT	OLO	BLUE BELT TECHNOLOGIES			00885556628416

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Required Intervention	ISOLATION TRANSFORMER/UPS, U.S.\| ISOLATION TRANSFORMER/UPS, U.S.\| ISOLATION TRANSFORMER/UPS, U.S.\| NAVIO SURGICAL SYSTEM CPU: 200509, (B)(6)\| NAVIO SURGICAL SYSTEM CPU: 200509, (B)(6)\| ISOLATION TRANSFORMER/UPS, U.S.