MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE ROBOTIC DRILL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10013

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when inserting the bur during the setup phase during a cori assisted ukr surgery, a system time out (the robotic drill has been deactivated) message prompted after pressing the ¿unlock¿ button ((b)(4)).Multiple attempts to recover were conducted including pressing ¿continue¿, ¿quit¿ and exiting out of the case and resuming the case.They disconnected the drill multiple times and had an equipment swap with two drills.The same error messages continued to persist and a full reboot of the system was conducted with no resolution ((b)(4)).A "communication failure" message and an internal error (the system has detected the application unexpectedly exited) were prompted ((b)(4)).They presumed that there was a connection problem associated with the console.So they borrowed a new cori console and tray from a nearby facility.They plugged in two of the previous "bad drills" into the brand new console and the error message still prompted.Therefore, the issue was caused by the drills and not the console ((b)(4)).To recover they used a new drill from a different facility and plugged that in to the new console and they were able to proceed with the case.The procedure was completed with a delay of over one hour with the patient under anesthesia and open on the table by using the s+n back-up device.The outcome of the patient¿s surgery was successful and there was no harm to the patient due to this error.

Manufacturer Narrative

H3, h6: the cori drill, p/n rob10013, sn (b)(6), reportedly used in treatment, was returned for evaluation.The case files were also provided, where only case id: (b)(4) was conducted on the field report¿s occurrence date of (b)(6) 2021.The reported system time out errors were confirmed in screenshot review.However, these errors were associated with robotic drill pn: rob10013, sn (b)(6).Robotic drill sn (b)(6) was not used in this case.The necessary log files (naviosystem.Log and xsession.Log) were not provided to identify the error resulting in the system console is bad error message (associated with sn (b)(6)).A visual and functional evaluation of sn (b)(6) was conducted where no non-conformances were identified.The drill operated as intended.Because there were no functional issues with the drill, the reported system time out errors may be due to an intermittent wiring/connection issue between the exposure motor and the tcu board.Robotic drill pn: rob10013, sn (b)(6) was also returned for a visual and functional evaluation and no non-conformances were identified.A possible contributing factor for the system time out errors (solely based on what was reported, not confirmed in the screenshot or navio.Log file review) may be due to an intermittent wiring/connection issue between the exposure motor and the tcu board.This situation is captured in the risk assessment released at the time of the complaint.The failure mode and associated risk have been anticipated within the risk file and that the documented risk level is still adequate.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports.A review of prior escalation actions was performed and found no actions that are applicable to the scope of the reported complaint.This issue will be continuously monitored through complaint investigation and post market surveillance.Based on the investigation, no containment or corrective actions are recommended at this time.

Manufacturer Narrative

H3, h6, h7, h9: the cori drill, p/n rob10013, (b)(6), reportedly used in treatment, was returned for evaluation.The case files were also provided, where only case id: (b)(4) was conducted on the field report¿s occurrence date of 13sep2021.The reported system time out errors were confirmed in screenshot review.However, these errors were associated with robotic drill pn: rob10013, (b)(6).Robotic drill sn500169 was not used in this case.The necessary log files (naviosystem.Log and xsession.Log) were not provided to identify the error resulting in the system console is bad error message (associated with (b)(6)).A visual and functional evaluation of (b)(6) was conducted where no non-conformances were identified.The drill operated as intended.Because there were no functional issues with the drill, the reported system time out errors may be due to an intermittent wiring/connection issue between the exposure motor and the tcu board.Robotic drill pn: rob10013, (b)(6) was also returned for a visual and functional evaluation and no non-conformances were identified.Although the reported problem was not confirmed through a visual, functional evaluation or log files, factors that may have contributed to the reported symptom may be associated with an intermittent 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.This situation is captured in the risk assessment released at the time of the complaint.The failure mode and associated risk have been anticipated within the risk file and that the documented risk level is still adequate.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports.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.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.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.

• Brand Name: REAL INTELLIGENCE ROBOTIC DRILL
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12544011
• MDR Text Key: 282416897
• Report Number: 3010266064-2021-00679
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 00885556757321
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10013
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES# 93620
• Patient Sequence Number: 1