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

Model Number ROB10024

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Loss of Range of Motion (2032); Fibrosis (3167)

Event Date 11/05/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that after a cori assisted tka surgery had been performed on (b)(6) 2021, the patient experienced arthrofibrosis in the right knee.This adverse event was treated with a manipulation under anesthesia on (b)(6) 2021.And it has been stated that the adverse event is definitely related to the cori procedure.The patient is recovering.

Event Description

It was reported that after a cori assisted tka surgery had been performed on (b)(6) 2021, the patient experienced arthrofibrosis in the right knee.This adverse event was treated with a manipulation under anesthesia on (b)(6) 2021.Since the patient had no progress after this intervention, a second manipulation under anesthesia was scheduled for (b)(6) 2021.It has been stated that the adverse event was definitely related to the cori procedure.Patient was recovered by (b)(6) 2022.

Manufacturer Narrative

Corrected data: b1, b2, b5, g2.

Manufacturer Narrative

H3, h6: the real intelligence cori, part number rob10024, 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.The clinical/medical investigation concluded that based on the information provided, the root cause of the reported ¿patient experienced right knee arthrofibrosis,¿ cannot be definitively concluded.However, arthrofibrosis is a known post-operative finding and not indicative of a component or the cori system malperformance.It is unknown if the 5-degree valgus outcome could be a contributing factor.The patient impact is the arthrofibrosis, limited range of motion, mua and the continued arthrofibrosis post first mua reportedly, requiring a second mua (scheduled december 8, 2021).The patient¿s current health status is unknown.No further patient impact can be determined, and no further medical assessment can be rendered.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.As with any surgical procedure, there is risk involved.Potential complications accompanying surgery may occur, including: allergic reaction (anaphylactic and minor), infection, mild to serious physical injury, localized static shock, delay in the operation, surgical site nerve injury, vascular injuries of the lower extremity, soft tissue damage, major bone gouging at the surgical site, bone fracture, immature implant failure, unstable knee joint, limited or restricted knee range of motion, major blunt impact injury, unintended laceration/puncture wound, and osteonecrosis.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 no reasonable contributing factors could be identified based on the received complaint information.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

Corrected data: b5.

Event Description

It was reported that after a cori assisted tka surgery had been performed on (b)(6) 2021, the patient experienced arthrofibrosis in the right knee.This adverse event was treated with a manipulation under anesthesia on (b)(6) 2021.Since the patient had no progress after this intervention, a second manipulation under anesthesia was scheduled for (b)(6) 2021.It has been stated that the adverse event is definitely related to the cori procedure.Patient was recovered by (b)(6) 2021.

Manufacturer Narrative

The real intelligence cori, part number rob10024, 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.The clinical/medical investigation concluded that based on the information provided, the root cause of the reported ¿patient experienced right knee arthrofibrosis,¿ cannot be definitively concluded.However, arthrofibrosis is a known post-operative finding and not indicative of a component or the cori system malperformance.It is unknown if the 5-degree valgus outcome could be a contributing factor.The patient impact is the arthrofibrosis, limited range of motion, mua and the continued arthrofibrosis post first mua reportedly, requiring a second mua (scheduled december 8, 2021).The patient¿s current health status is unknown.No further patient impact can be determined, and no further medical assessment can be rendered.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.As with any surgical procedure, there is risk involved.Potential complications accompanying surgery may occur, including: allergic reaction (anaphylactic and minor), infection, mild to serious physical injury, localized static shock, delay in the operation, surgical site nerve injury, vascular injuries of the lower extremity, soft tissue damage, major bone gouging at the surgical site, bone fracture, immature implant failure, unstable knee joint, limited or restricted knee range of motion, major blunt impact injury, unintended laceration/puncture wound, and osteonecrosis.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.No reasonable contributing factors could be identified based on the received complaint information and investigation results.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 cori, part number rob10024, (b)(6), intended for use in treatment was returned for evaluation.A relationship between the reported event and the device could not be established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed, and the reported problem was not confirmed, the cori console functioned as intended.A kpc test, case, and calibration were all completed without error.The software files were downloaded from the device and provided for investigation.The log files do not indicate any system or software issue related to the reported complaint.The screenshots were reviewed with clinical account representatives and the reported complaint could not be confirmed.No definitive conclusions could be drawn from the plan, as there did not appear to be any abnormalities.Although the reported problem was not confirmed through a visual or functional evaluation, it was noted that the surgeon could have planned for a looser gap when the knee was in extension and could be a possible contributing factor in the reported arthrofibrosis.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 1 similar event.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.As with any surgical procedure, there is risk involved.Potential complications accompanying surgery may occur, including: allergic reaction (anaphylactic and minor), infection, mild to serious physical injury, localized static shock, delay in the operation, surgical site nerve injury, vascular injuries of the lower extremity, soft tissue damage, major bone gouging at the surgical site, bone fracture, immature implant failure, unstable knee joint, limited or restricted knee range of motion, major blunt impact injury, unintended laceration/puncture wound, and osteonecrosis.The risk review could not be completed as insufficient information was provided that relates the specific failure mode to the device.This case reports, the patient experienced right knee arthrofibrosis and subsequent manipulation under anesthesia procedure approximately 1 month after a tka surgery was performed.Per case communication, the patient is scheduled for a second manipulation under anesthesia due to ¿continued arthrofibrosis¿ at the (b)(6) 2021 office visit.The crf documented, the adverse event ¿is definitely related¿ to the cori procedure.Reportedly, ¿the patient is still recovering.¿ mua procedure report initial findings, range of motion was 5 to 50 degrees, the surgeon was able to mobilize the patella, full extension was achieved, gentle flexion added, and a range of motion increased to 130 degrees.However, no information has been received regarding the second (scheduled) mua as of the date of this assessment.The crf operative data notes the planned leg alignment was zero degrees valgus with a post-cementation alignment was 5 degrees valgus.The primary operative note did document no complications with good tracking.The patient¿s current health status is unknown.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.Conclusion: based on the information provided, the root cause of the reported ¿patient experienced right knee arthrofibrosis,¿ cannot be definitively concluded.However, arthrofibrosis is a known post-operative finding and not indicative of a component or the cori system malperformance.It is unknown if the 5-degree valgus outcome could be a contributing factor.The patient impact is the arthrofibrosis, limited range of motion, mua and the continued arthrofibrosis post first mua reportedly, requiring a second mua (scheduled (b)(6) 2021).The patient¿s current health status is unknown.No further patient impact can be determined, and no further medical assessment can be rendered.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.

• Brand Name: REAL INTELLIGENCE CORI
• 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: 12869119
• MDR Text Key: 281205494
• Report Number: 3010266064-2021-00799
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 00885556757420
• 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: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ROB10024
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 07/25/2022; 09/09/2022; 09/09/2022; 10/24/2022; 11/14/2022
• Supplement Dates FDA Received: 07/29/2022; 09/23/2022; 10/17/2022; 10/26/2022; 11/17/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 91 KG