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); Physical Resistance/Sticking (4012); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 06/28/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference:(b)(4).

Event Description

It was reported that, upon calibration in a tka surgery assisted with cori, the real intelligence robotic drill immediately got a drill disconnecting error.The surgeon then tried to bypass the error and the whole system froze and was flashing between showing the real intelligence robotic drill connected and disconnected.They did a hard shutdown on the system since it was frozen.Upon rebooting the console, they tried to reload the case and again the system froze up.The procedure was completed with manual instrumentation without significant delays.The patient was not harmed beyond the reported problem.In addition, the robotic drill attachment is now locked onto the real intelligence robotic drill.

Manufacturer Narrative

H3, h6: the real intelligence robotic drill, part number rob10013, serial number (b)(6), intended for treatment was not returned for evaluation.An image was provided.A relationship between the reported event and the device was established.The clinical/medical investigation concluded that the field report images confirm the ri drill deactivation screen notification; however, does not provide insight into the root cause of the reported event.It was also reported that the ri drill/burr attachment is now locked onto the ri drill ((b)(4)).Patient impact beyond the reported 0-30 minute surgical delay, abandoning the "locked-up" cori system and subsequent use of manual instrumentation to perform the tka procedure would not be anticipated as manual procedure/standardized instrumentation is an approved surgical technique and no patient harm was alleged due to the reported event.No further medical assessment could be rendered at this time.The reported problem was confirmed with a visual inspection.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.Refer to the real intelligence cori for knee arthroplasty user manual, section setting up a cori knee procedure: setting up the instruments, connecting the robotic drill for proper set up and handling.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.The most likely cause of this event is associated with an internal drill motor connection issue.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

H3, h6: the robotic drill p/n rob10013, (b)(6), used for treatment was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.The drill showed a critical error at the start of kpc & the system froze during a case.The drill led on the console was flashing.The attachment could not be removed manually nor during kpc unlock.Disassembly revealed nothing unusual and the attachment was removed.The attachment nut was torqued to spec.Multimeter testing of the exposure motor showed no voltage from pin 6.Replacement of the exposure motor eliminated all reported issues.The most likely cause of this event is the failure of the drill exposure motor encoder.A review of manufacturing and service records indicates 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 however no further escalation action is required.Refer to the real intelligence cori for knee arthroplasty user manual, section setting up a cori knee procedure: setting up the instruments, connecting the robotic drill for proper set up and handling.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

H3, h6, h7, h9: the robotic drill p/n rob10013, sn(b)(6), used for treatment was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.The drill showed a critical error at the start of kpc & the system froze during a case.The drill led on the console was flashing.The attachment could not be removed manually nor during kpc unlock.Disassembly revealed nothing unusual and the attachment was removed.The attachment nut was torqued to spec.Multimeter testing of the exposure motor showed no voltage from pin 6.Replacement of the exposure motor eliminated all reported issues.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 indicates 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.Refer to the real intelligence cori for knee arthroplasty user manual, section setting up a cori knee procedure: setting up the instruments, connecting the robotic drill for proper set up and handling.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.

• 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: 15070853
• MDR Text Key: 296287065
• Report Number: 3010266064-2022-00527
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• 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: PN: ROB10014 / SERIAL NUMBER: UNKNOWN.; PN: ROB10015 / SERIAL NUMBER: UNKNOWN.; PN: ROB10024 / SERIAL NUMBER: (B)(6).
• Patient Outcome(s): Required Intervention; Hospitalization