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

Catalog Number ROB10024

Device Problem Application Program Problem: Parameter Calculation Error (1449)

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

Event Date 03/26/2024

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference case (b)(4).

Event Description

It was reported that during a cori assisted tka, patient had a 4-degree valgus deformity and surgeon planned for 2mm gaps through extension and flexion on the real intelligence cori.By the time he got to trialing, he realized that his flexion gap was looser than what he expected, and his extension gap was tighter than expected.He ended up having to go back and take an additional 6mm off the distal femur to open his extension gap.Which was something he said he had never done ever before.Surgery was performed, without any delay, with the same devices.Patient's current health status is unknown.

Manufacturer Narrative

H3, h6: the real intelligence cori, rob10024, sn000498, used for treatment was not returned for evaluation.A visual and functional evaluation could not be performed and a relationship between the reported event and the device could not be determined.Screenshots and system log files provided were reviewed with the software support and clinical support teams.The reported problem was confirmed, the screenshots show that the surgeon cut an additional 6mm than initially planned for.The log files and screenshots do not show if the flexion gap was looser than the surgeon expected or that the extension gap was tighter than expected.The screenshots do show a planned extension gap of 7.2 mm medially and 5.4 mm laterally, as well as a flexion gap of 2.2 mm medially and 2.3 mm laterally.The implant looks appropriately sized, and it appears that the surgeon¿s first distal cut was minimal.It is possible that there were posterior osteophytes that were not removed before planning.The system logfiles do not indicate whether the surgeon was properly collecting the neutral position or rom collection.The most likely cause of the reported complaint is a known software defect.We are actively examining this defect to determine the appropriate course of action.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.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.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.

• 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: 19148968
• MDR Text Key: 340690119
• Report Number: 3010266064-2024-00090
• Device Sequence Number: 1
• Product Code: OLO
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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