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

Catalog Number ROB10013

Device Problem Connection Problem (2900)

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

Event Date 07/04/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during a cori-assisted tka, when connecting the real intelligence robotic drill, the control lamp was flashing steadily.The program could not be continued.During the subsequent check in the control program, the message appeared: "robotic drill critical error: the robotic drill has an internal error." surgery was performed, without any delay, changing to manual procedure.No patient complications were reported.

Manufacturer Narrative

Section h10: the cori drill rob10013, (b)(6), used in treatment, was returned for evaluation.Nothing was visually identified that contributes to the reported failure.A functional evaluation was performed.The reported failure that a ¿critical error¿ and an ¿internal error¿ appeared, can be confirmed.A kpc test was performed, the drill failed all tests, and then prompted a ¿critical error¿.The led light on the console also was blinking.When moving the cable around and pressing ¿continue¿ on the notifications tab, the drill worked again.This was repeated multiple times, and the same error occurred.A test case was performed, while burring a ¿communication error¿ occurred which was followed by a ¿critical error¿.The drill was opened for further investigation.The drill motor is functioning properly.The exposure motor was measured and passed.The cable was replaced with a known to work one.The kpc test and test case were performed, in both cases no failures/errors could be found.An engineering review was completed.The reported problem was not confirmed.The exposure motor was tested and found to be responsive.The most likely cause for this event is a damaged cable.A review of the manufacturing records found no related non-conformances or anomalies associated with this serial number during production.No service records were identified prior to the complaint date for this device.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 the reported complaint.The real intelligence cori for knee arthroplasty user manual provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines, appendix d".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, the failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.Internal complaint reference number: (b)(4).

Manufacturer Narrative

Section h10: the cori drill rob10013, (b)(6) used in treatment, was returned for evaluation.Nothing was visually identified that contributes to the reported failure.A functional evaluation was performed.The reported failure that a ¿critical error¿ and an ¿internal error¿ appeared, can be confirmed.A kpc test was performed, the drill failed all tests, and then prompted a ¿critical error¿.The led light on the console also was blinking.When moving the cable around and pressing ¿continue¿ on the notifications tab, the drill worked again.This was repeated multiple times, and the same error occurred.A test case was performed, while burring a ¿communication error¿ occurred which was followed by a ¿critical error¿.The drill was opened for further investigation.The drill motor is functioning properly.The exposure motor was measured and passed.The cable was replaced with a known to work one.The kpc test and test case were performed, in both cases no failures/errors could be found.An engineering review was completed.The reported problem was not confirmed.The exposure motor was tested and found to be responsive.The most likely cause of this event is du to a damaged cable.Another factor 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.A review of the manufacturing records found no related non-conformances or anomalies associated with this serial number during production.No service records were identified prior to the complaint date for this device.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 real intelligence cori for knee arthroplasty user manual (500230 rev d) provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines, appendix d".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.Internal complaint reference number: (b)(4) section h6 were updated/corrected.

• 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: 17325791
• MDR Text Key: 319185249
• Report Number: 3010266064-2023-00127
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• 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: A
• Removal/Correction Number: RES# 93620
• Patient Sequence Number: 1