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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 Unspecified Tissue Injury (4559)
Event Date 03/21/2022
Event Type  Injury  
Event Description
It was reported that, during cori assisted tka, the anterior femur was notched by 3mms. The surgeon used the bur distal approach with punch tool then placed the size 4 cutting block, but the system sized for a size 5. They adjusted the gaps and resection to appropriate position, but the anterior cut was below the implant flange and conservative. Final planning screen showed an aggressive but 0. 5 mm into notch warning anterior cut (the surgeon used a wide angle sawblade). Initially, the femur trial would not fit and surgeon had to put on the size 4 cutting block again to check the cuts. They were still able to move more bone, but trial did not sit flush.
 
Manufacturer Narrative
Internal complaint reference:(b)(6).
 
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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 Key14104617
MDR Text Key289207973
Report Number3010266064-2022-00282
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193120
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? Yes
Device Operator
Device Model NumberROB10024
Device Catalogue NumberROB10024
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/13/2022 Patient Sequence Number: 1
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