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

Model Number ROB10013

Device Problems Intermittent Continuity (1121); Overheating of Device (1437); Connection Problem (2900); Noise, Audible (3273)

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

Event Date 03/14/2022

Event Type  malfunction  

Event Description

It was reported that during a cori assisted tka surgery, the real intelligence robotic drill was making a noise as if the gears were off, and it also became quite hot.They tried recalibrating and closed out of the case a few times, but kept getting a disconnect error at the unlock screen of recalibration.The procedure was completed, with a significant delay, using a s+n back-up device.Patient was not harmed beyond the reported problem.

Manufacturer Narrative

Internal complaint reference: case(b)(4).

Manufacturer Narrative

The real intelligence robotic drill, part number rob10013, serial number (b)(6), used for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with internal exposure motor connectivity issues.Based on the investigation, the need for a corrective action is not recommended or required at this time.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.

Manufacturer Narrative

The real intelligence robotic drill, part number rob10013, sn(b)(6), used for 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 partially confirmed.(there was a disconnect error).After attempting to run a case with the drill, a system timeout loop occurred during the ¿setup¿ screen.This is likely what the complaint refers to as the ¿disconnect error¿.After using a new drill attachment and drill attachment retaining nut, the drill performed without issue.There were no overheat errors that were displayed, and subjectively the noise level was acceptable.The most likely cause of this event may have been associated with a loose/malformed drill attachment retaining nut.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.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.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.

Manufacturer Narrative

H7: if remedial action initiated, check type and h9: if action reported to fda under 21 usc 360i(f), list correction/removal reporting number.Section h3, h6: the real intelligence robotic drill, part number rob10013, (b)(6), used for 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 partially confirmed.(there was a disconnect error).After attempting to run a case with the drill, a system timeout loop occurred during the ¿setup¿ screen.This is likely what the complaint refers to as the ¿disconnect error¿.After using a new drill attachment and drill attachment retaining nut, the drill performed without issue.There were no overheat errors that were displayed, and subjectively the noise level was acceptable.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 found similar 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 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.H6: medical device problem code, component code, type of investigation, investigation findings and investigation conclusions.

• 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: 14007440
• MDR Text Key: 288589643
• Report Number: 3010266064-2022-00247
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• 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
• Is the Reporter a Health Professional?: Yes
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: CORI ROBOTICS USA; REAL INTELLIGENCE ROBOTIC DRILL TRACKER; RI ROBOTIC DRILL ATTACHMENT
• Patient Sex: Male