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

Catalog Number ROB10024

Device Problems Application Program Problem: Parameter Calculation Error (1449); Data Problem (3196)

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

Event Date 03/28/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that, during a cori assisted tka surgery, while trialing, during final stress the surgeon complained/remarked the final stress was much tighter than what he had planned.Surgeon wants to put in a 11/13 insert and instead is stuck with 9/10 insert going in.The surgery was completed, without any delay, with the 9/10 insert no injuries were reported.

Manufacturer Narrative

The real intelligence cori, part number rob10024, serial number (b)(6), used for treatment was not returned for evaluation, therefore a device analysis was unable to be performed.System log files or screenshots were not provided for investigation, as such a thorough investigation could not be performed.Should screenshots or system log files become available, the case can be reopened.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.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.A historical escalation event review was not completed.The product was not returned and no evidence was made available to link the complaint to an escalation event.We have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with user technique/variance.Based on the investigation, no containment or corrective action is 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.

• 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: 19116225
• MDR Text Key: 341004687
• Report Number: 3010266064-2024-00088
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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: 03/28/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 05/09/2024
• Supplement Dates FDA Received: 05/15/2024
• 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: Unknown
• Patient Sequence Number: 1