MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES RI ROBOTIC DRILL ATTACHMENT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number ROB10013

Device Problems Connection Problem (2900); Physical Resistance/Sticking (4012)

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

Event Date 08/02/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference (b)(6).

Event Description

It was reported that, during a cori assisted tka surgery, at the beginning of the operation, there were some issues regarding the ri robotic drill attachment, the real intelligence robotic drill and the real intelligence robotic drill tracker.The cutter could not be set, the following error messages were displayed: communication failure / internal error / critical error.The robotic drill could also not be disassembled.The surgery was completed, without any delay, changing to manual procedure.No injuries were reported.

Manufacturer Narrative

Section h10: the cori drill rob10013, (b)(6), used during treatment, was returned for evaluation.Nothing was visually identified that contributes to the reported problem.A functional test was performed, and the reported scenario was confirmed, a communication failure, internal error, and critical error were shown.The drill attachment could be removed manually at first, but when attempting a kpc test, the drill attachment got stuck.When doing a kpc test, the burr was not able to be loaded as the motors did not respond, and then a critical error appeared.The light for the console started flashing and missing rom was shown.This was resolved by unplugging the drill and inserting it again.The drill was opened for further investigation, and the drill attachment and tracker were freed.The exposure motor was tested and passed.When performing a test case, a communication error occurred, followed by an internal error message.A known working cable was used and a kpc test and test case were performed without error.The drill attachment and tracker could also be removed and put on multiple times without issue.An engineering review was completed.The exposure motor was tested and found to be responsive.The most likely cause of the reported event is due to a damaged cable.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.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 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.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.Definitive contributing clinical factors cannot be concluded based on the information provided.Patient impact beyond the conversion to a manual tka (which is an approved surgical technique/recovery procedure) would not be anticipated as there was no surgical delay, further complications or patient injury reported.No further medical assessment is warranted at this time.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: case (b)(4).

Manufacturer Narrative

Section h10: the cori drill rob10013, (b)(6) used during treatment, was returned for evaluation.Nothing was visually identified that contributes to the reported problem.A functional test was performed, and the reported scenario was confirmed, a communication failure, internal error, and critical error were shown.The drill attachment could be removed manually at first, but when attempting a kpc test, the drill attachment got stuck.When doing a kpc test, the burr was not able to be loaded as the motors did not respond, and then a critical error appeared.The light for the console started flashing and missing rom was shown.This was resolved by unplugging the drill and inserting it again.The drill was opened for further investigation, and the drill attachment and tracker were freed.The exposure motor was tested and passed.When performing a test case, a communication error occurred, followed by an internal error message.A known working cable was used and a kpc test and test case were performed without error.The drill attachment and tracker could also be removed and put on multiple times without issue.An engineering review was completed.The exposure motor was tested and found to be responsive.The most likely cause of the reported event is due 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 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.The real intelligence cori for knee arthroplasty user 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.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.Definitive contributing clinical factors cannot be concluded based on the information provided.Patient impact beyond the conversion to a manual tka (which is an approved surgical technique/recovery procedure) would not be anticipated as there was no surgical delay, further complications or patient injury reported.No further medical assessment is warranted at this time.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 was updated/corrected.

• Brand Name: RI ROBOTIC DRILL ATTACHMENT
• 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: 17638486
• MDR Text Key: 322134568
• Report Number: 3010266064-2023-00141
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• 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: 08/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2023
• 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: Unknown
• Removal/Correction Number: RES# 93620
• Patient Sequence Number: 1
• Treatment: CORI (ROB10024/(B)(6)); DRILL ATTACHMENT (ROB10015/(B)(6)); DRILL TRACKER (ROB10014/UNKNOWN); REAL INTELLIGENCE CORI(PN:ROB10024,(B)(6)); RI ROB DRILL TRACKER(PN:ROB10014); RI ROB DRILL(PN:ROB10013,(B)(6))
• Patient Outcome(s): Required Intervention