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

Model Number ROB10024

Device Problems Application Program Problem: Parameter Calculation Error (1449); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Laceration(s) (1946); Unspecified Tissue Injury (4559)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during a cori tka procedure, the surgeon believed that the system did not act as it should and that it overcut on the lateral edge of a distal femur bur cut.The bur extended past cut zone on the lateral edge.It did not impact overall outcome.No patient injury or other complications were reported.

Manufacturer Narrative

H3, h6: the real intelligence cori, pn: rob10024, sn: (b)(6).Used for treatment was returned to the designated complaint unit for evaluation.Nothing was identified visually that contributed to the reported problem.The case files were provided and reviewed.Screenshots confirmed an overcut on the distal lateral edge of the femur.A picture of the physical knee also confirms the overcut in this location.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports, this issue will continue to be monitored.The clinical/medical evaluation concluded: ¿based on the information provided, the root cause of the reported event could not be definitively concluded, although a user/procedural variance could not be ruled out as a potential contributing factor (i.E.Speed and/or trajectory).The patient impact beyond the reported overcut of the lateral distal femur could not be determined; however, it was reported that the event ¿did not impact overall outcome or patient health¿.No further medical assessment could be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.¿ the most likely cause of this issue is that the user approached the bone from a lateral trajectory when in exposure mode.According to the cori user's manual, the user should avoid quick passes of the tool over the surface.To remove bulk bone, a slow, methodic ¿plunge and drag motion¿ through to the cortical layer, will remove bone with the greatest efficiency.The bur remains protruded only until it has reached the target surface, and the bur exposure actively adjusts so that cutting beyond the target surface is minimized.This situation is captured in the optimus risk assessment released at the time of the complaint.Further analysis of the software related to this event is being conducted by the software engineering team.No further containment or correction is required at this time.

Manufacturer Narrative

H3, h6: the real intelligence cori, pn: rob10024, sn: (b)(6) used for treatment was returned to the designated complaint unit for evaluation.Nothing was identified visually that contributed to the reported problem.The case files were provided and reviewed.Screenshots confirmed an overcut on the distal lateral edge of the femur.A picture of the physical knee also confirms the overcut in this location.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports, this issue will continue to be monitored.A historical escalation event review was completed.The review determined that prior escalation actions are applicable to the part number or serial number and scope of this complaint, and no further escalation action is required.The clinical/medical evaluation concluded: ¿based on the information provided, the root cause of the reported event could not be definitively concluded, although a user/procedural variance could not be ruled out as a potential contributing factor (i.E.Speed and/or trajectory).The patient impact beyond the reported overcut of the lateral distal femur could not be determined; however, it was reported that the event ¿did not impact overall outcome or patient health¿.No further medical assessment could be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.¿ the most likely cause of this event is associated with the a software defect.According to the cori user's manual, the user should avoid quick passes of the tool over the surface.To remove bulk bone, a slow, methodic ¿plunge and drag motion¿ through to the cortical layer, will remove bone with the greatest efficiency.The bur remains protruded only until it has reached the target surface, and the bur exposure actively adjusts so that cutting beyond the target surface is minimized.This situation is captured in the optimus risk assessment released at the time of the complaint.As part of corrective action, this software defect has been resolved on cori software version 1.7.1 and above.The failure mode will continue to be monitored through complaint investigation and trended through 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: 11543810
• MDR Text Key: 241491131
• Report Number: 3010266064-2021-00216
• 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: K201022
• 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: 06/06/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/22/2021
• Supplement Dates Manufacturer Received: 08/16/2021; 06/05/2024
• Supplement Dates FDA Received: 08/17/2021; 06/06/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention