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

Model Number ROB10013

Device Problems Intermittent Continuity (1121); Connection Problem (2900); Mechanics Altered (2984)

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

Event Date 01/14/2022

Event Type  malfunction  

Manufacturer Narrative

The real intelligence robotic drill 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 could not be completed successfully.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.The most likely cause of this event was that the drill exposure motor encoder is failing to communicate with the system console.A supplemental mdr will be sent with the complete results of investigation.Internal complaint reference number: (b)(4).

Event Description

It was reported that after the cori installation, they plugged in the real intelligence robotic drill to take it through the case registration process.Once they plugged it in on the connection screen, the row with the handpiece where the x would normally turn in to a green checkmark started flickering rapidly.They attempted to do a kpc test but the could not get past the first step where they got a message saying robotic drill critical error.They checked the pins on the handpiece cord but they could not see anything wrong.They had also made sure the handpiece was plugged in as far as it could go.They tested the handpiece on another cori console and had no issues.No case involved; therefore, there was no patient involvement.Upon investigation, it was found that the exposure motor was causing the real intelligence robotic drill to fail.

Manufacturer Narrative

H3, h6: the real intelligence robotic drill, p/n rob10013, sn (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 could not be completed successfully.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 is associated with an electrical component failure.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.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.

Manufacturer Narrative

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 could not be completed successfully.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.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.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.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.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.

• 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: 13758334
• MDR Text Key: 287347665
• Report Number: 3010266064-2022-00186
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• 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
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2024
• 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: Reuse
• Removal/Correction Number: RES# 93620
• Patient Sequence Number: 1
• Treatment: ROB10024, REAL INTELLIGENCE CORI, SERIAL (B)(6)