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

Model Number ROB10033

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2020

Event Type  Injury  

Event Description

It was reported that, during cori tka procedure, after performing bur all on the femur, completing all but the posterior condyles, surgeon sawed the posterior condyles and placed 4-in-1 cutting block.Surgeon exclaimed that there was 2-3mm of play, and said it was the loosest femur he has ever put in, and that he could not even trial it.Later on, during trialing, surgeon used screws to secure trial and was able to proceed.Plane checked the cuts and were within 1mm.The patient had a significant valgus deformity and had a hypoplastic posterolateral femoral condyle that did not make full contact with the virtual implant on the planning screen, which the surgeon accepted.Surgery was not delayed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that, during a cori assisted tka surgery, after performing bur all on the femur, completing all but the posterior condyles, surgeon sawed the posterior condyles and placed 4-in-1 cutting block.Then, surgeon exclaimed that there was 2-3mm of play, and said it was the loosest femur he had ever put in, and that he could not even trial it.Later on, during trialing, surgeon used screws to secure trial and was able to proceed.Plane checked the cuts and were within 1mm.The patient had a significant valgus deformity and had a hypoplastic posterolateral femoral condyle that did not make full contact with the virtual implant on the planning screen, which the surgeon accepted.The surgery was not delayed due to this incident.No further complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

The cori console p/n rob10024 sn(b)(6) used for treatment was returned.There were no visual or functional abnormalities related to the reported complaint.The cori log files were provided, and there did not appear to be any system abnormalities.However, the userdatabase folder containing the screenshots for the 19-oct-2020 occurrence date was not provided for review.Therefore the reported issue could not be confirmed.The logs were also pulled from the console, and there was no userdatabase file for the occurrence date.Although the case screenshots could not be reviewed to confirm the reported complaint, the complaint description was reviewed with clinical account representatives.It was determined that the order in which the user executed the cuts per the complaint description could not be discerned.Typically the posterior condyles would have been removed with the cut block, however, the complaint indicates the posterior condyles were removed prior to placing the cutting block.It is also unknown whether the ¿2-3 mm of play¿ was for the entire range of motion of the knee, nor is it known whether this ¿2-3 mm of play¿ was with the trial on or not.A contributing factor for the looseness of the femur could be the cut block not having been dialed in to the neutral position.The user may have accidentally taken more posterior bone than intended if the dial was positioned to resect additional bone.Cori is a surgical tool designed to provide assistance to the surgeon; it is not a substitute for the surgeon¿s experience and skill.The surgeon is responsible for implant planning and the conduct of the surgery during which cori is being used.The clinical/medical evaluation concluded: ¿per complaint details, the device (bullet burr/cori) malfunctioned during the tka after bur-all on the femur and the surgeon sawed the posterior condyles and placed 4-in-1 cutting block and resulted in ¿the loosest femur¿.Reportedly, ¿screws were used to secure the trial and was able to proceed¿ without additional interventions.Per the field report, there was no impact on the case and the ¿plane checked the cuts and were within 1mm¿.No patient injury or surgical delay was reported.Per correspondence no additional interventions were necessary due to the reported event and the surgeon was ultimately satisfied with the surgical outcome; however, requested clinical documentation was not available for inclusion in the medical investigation.Based on the information provided the patient impact beyond the reported modified procedure would not be anticipated as the outcome was reportedly satisfactory.No further medical assessment could be rendered at this time.Should additional clinical/medical information/documentation become available, the clinical/medical task may be re-opened for further evaluation.¿ this situation is captured in the risk assessment released at the time of the complaint.The failure mode and associated risk have been anticipated within the risk file and that the documented risk level is still adequate.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports.A review of prior escalation actions was performed and found no actions that are applicable to the scope of the reported complaint.This issue will be continuously monitored through complaint investigation and post market surveillance.Based on the investigation, no containment or corrective actions are recommended at this time.

• 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; suite 100; austin, TX 78735 ; 5123913905
• MDR Report Key: 10813100
• MDR Text Key: 215472621
• Report Number: 3010266064-2020-01970
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10033
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: ROB20000
• Patient Outcome(s): Required Intervention