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); Noise, Audible (3273)

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

Event Date 12/10/2020

Event Type  Injury  

Event Description

It was reported that during a cori tka procedure, several "robotic drill disconnect" errors were displayed, and were not resolved by troubleshooting.Although they recommended either rebooting the system or opening another drill (unknown which is causing the issue), the surgeon proceeded with manual instrumentation.There was a delay of greater than 30 minutes.After the procedure, they performed a drill test and received a message "robotic drill critical error".After disconnecting and reconnecting the drill twice, they were able to bypass this error, but the drill continued to operate in an unusual manner, with excessive clicking noises and "jumping" at the nose of the drill.No other complications were reported.

Manufacturer Narrative

H3, h6: the real intelligence robotic drill, part number rob00013, s/n (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 review was completed.The reported problem was not confirmed.The drill was able to pass kpc testing and functioned as designed during a mock saw bones case.A log file review was performed.The log file review confirmed the reported multiple drill disconnect errors.The most likely cause of this event is related to an internal loose connection in the motor.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.The review determined that prior escalation actions are applicable to the scope of this complaint and the capa owner has been notified to consider further escalation action.The real intelligence cori for knee arthroplasty user manual provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines".The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details, the "drill disconnect¿ error occurred during a cori tka procedure and troubleshooting resulted in further error messages.Reportedly, the surgeon decided to proceed with manual instrumentation which resulted in a ¿greater than 30-minute¿ surgical delay.However, no patient injury was reported, and it was communicated that ¿the patient¿s health is good¿.Per correspondence, operative reports are not available; however, no patient harm/injury resulted in the case and no other interventions were reported.The procedure was reportedly completed manually with a 30-plus-minute surgical extension without report of patient injury/harm; therefore, no further patient impact would be anticipated.No further medical assessment is warranted at this time.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

H2: additional information ¿h6: medical device problem code¿.

Manufacturer Narrative

H3, h6: the real intelligence robotic drill, part number rob00013, s/n (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 review was completed.The reported problem was not confirmed.The drill was able to pass kpc testing and functioned as designed during a mock saw bones case.A log file review was performed.The log file review confirmed the reported multiple drill disconnect errors.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.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.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 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 real intelligence cori for knee arthroplasty user manual provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines".The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details, the "drill disconnect¿ error occurred during a cori tka procedure and troubleshooting resulted in further error messages.Reportedly, the surgeon decided to proceed with manual instrumentation which resulted in a ¿greater than 30-minute¿ surgical delay.However, no patient injury was reported, and it was communicated that ¿the patient¿s health is good¿.Per correspondence, operative reports are not available; however, no patient harm/injury resulted in the case and no other interventions were reported.The procedure was reportedly completed manually with a 30-plus-minute surgical extension without report of patient injury/harm; therefore, no further patient impact would be anticipated.No further medical assessment is warranted 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.

• 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: 11100194
• MDR Text Key: 224517098
• Report Number: 3010266064-2020-02151
• 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: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: Yes
• 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: 12/21/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention