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 06/28/2021

Event Type  Injury  

Event Description

It was reported that, after a cori-assisted tka surgery performed on (b)(6) 2021, the patient presented arthrofibrosis in the right knee.A revision surgery was set to be performed on the (b)(6) 2021 to treat this adverse event.The patient current health status is unknown.

Manufacturer Narrative

The product, ri cori (us), rob10024, (b)(6) used for treatment was not returned for evaluation, however pre and post operative reports were provided for review.Per the operative note, the manipulation under anesthesia was performed due to arthrofibrosis.Arthrofibrosis is a well-known potential post-operative occurrence and does not support a component malperformance, therefore a relationship between the reported event and the device was not confirmed.A functional evaluation could not be performed because the device was not returned.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 has identified prior events.The cause of this adverse event is undeterminable.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 assessment notes the intended use, indication for use and design assumptions of the cori system.Per the operative note the mua was performed due to arthrofibrosis.The range of motion increased intraoperatively to ¿satisfactory¿.Arthrofibrosis is a well-known potential post-operative occurrence and does not support a component malperformance.Patient¿s health impact is unknown beyond the stated information provided.A review of the provided documents did not provide any insight into the reported issue of right knee arthrofibrosis requiring a manipulation procedure.Therefore, no further clinical assessment of the reported issue can be rendered.Should additional information be provided, the clinical/medical investigation task may be reopened.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

Manufacturer Narrative

Additional information: b5, d10, h6.

Event Description

It was reported that, after a cori-assisted tka surgery performed on (b)(6) 2021, the patient developed arthrofibrosis in the right knee (symptom onset: (b)(6) 2021).The patient underwent manipulation under anesthesia on (b)(6) 2021 to treat this adverse event.On the (b)(6) 2021 the patient was appointed as recovered.

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 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.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.Per the operative note the mua was performed due to arthrofibrosis.The range of motion increased intraoperatively to ¿satisfactory¿.Arthrofibrosis is a well-known potential post-operative occurrence and does not support a component malperformance.Patient¿s health impact is unknown beyond the stated information provided.A review of the provided documents did not provide any insight into the reported issue of right knee arthrofibrosis requiring a manipulation procedure.Therefore, no further clinical assessment of the reported issue can be rendered.Should additional information be provided, the clinical/medical investigation task may be reopened.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: 12201331
• MDR Text Key: 262617755
• Report Number: 3010266064-2021-00555
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10024
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2022
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: JOURNEY TIBIA BASE NP RT SZ 7 / (B)(6); JRNY BCS PAT RESRF RD 35 MM STD /(B)(6); JRNY II CR ISRT XLPE RT SZ 7-8 9MM / (B)(6)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 112 KG