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U.S. Department of Health and Human Services

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

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BLUE BELT TECHNOLOGIES REAL INTELLIGENCE CORI ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number ROB10024
Device Problem Application Program Problem: Parameter Calculation Error (1449)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/24/2020
Event Type  Injury  
Manufacturer Narrative
The real intelligence cori used for treatment was not returned to the designated complaint unit for evaluation, therefore, visual and functional inspections could not be performed. Although the product was not returned 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. There were no user-taken screenshots to show the position of the virtual bur flush against the ap plane of the tibia, or the bur perpendicular to the tibial plateau. The user failed checkpoint verification after the first round of tibia bone removal. Log file review found several tibia checkpoint verification attempts with errors ranging from 1. 54 to 1. 68 mm off (threshold is 1. 5 mm). The user then redefined the checkpoints and then began the second round of tibia bone removal. Additional red was observed on the tibial plateau following the checkpoint redefinition. It is likely that the tibia tracker had moved prior to the initial cut, and redefining the tibia checkpoint afterward may have contributed to the additional red. Bone tracker movement shifts the entire virtual bone model from its original position defined in the checkpoint definition screen. The drill and bur are then mislocated in relation to the virtual bone model. Redefinition of checkpoints should only occur if the user is confident that nothing has moved. If a tracker has moved and the checkpoint is redefined, the user needs to start the case over so that the registration steps are re-done to realign the virtual bone model to the physical knee. It should be noted that the patient had significant wear on the medial side of the tibia. The medial side was likely denser because it had been compressed. The plan also showed 13 mm of the lateral side to be re-sected. This is a significant amount of bone to remove, and this depth is typically where the spongey bone is. This bone would be more susceptible to the bur guard pressing down slightly past the target surface and a possible contributing factor for the red on the lateral side of the plateau. Internal complaint reference number: (b)(4).
 
Event Description
It was reported that during a cori assisted tka procedure, when the bur was flush against the tibia in the ap plane with the drill/handpiece in speed mode, it registers fine for cutting on the bone surface. But when they moved the hand piece to a vertical orientation facing down towards the tibial plateau, the software registers is as over-resecting by a few millimeters. There was a delay of fewer than 30 minutes. No other complications were reported. Upon investigation, it was found that the plan also showed 13 mm of the lateral side to be resected. This is a significant amount of bone to remove, and this depth is typically where the spongey bone is. This bone would be more susceptible to the bur guard pressing down slightly past the target surface and a possible contributing factor for the red on the lateral side of the plateau.
 
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Brand NameREAL INTELLIGENCE CORI
Type of DeviceORTHOPEDIC 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 Key14102933
MDR Text Key289189134
Report Number3010266064-2022-00281
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberROB10024
Device Catalogue NumberROB10024
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/07/2022
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 Treatment Data
Date Received: 04/13/2022 Patient Sequence Number: 1
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