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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM AU ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM AU ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number NPFS02070
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/15/2020
Event Type  Injury  
Event Description
It was reported that during a tka procedure, there was an unexpected joint laxity whilst trialing, it was planned for a 9mm poly and ended up with an 18 mm poly and still laxity medially in high flexion with an 18mm. The case proceeded as normal and without issue. Then the tibial twin peg drill holes noted to be not in bone, tibial resection increased to 11 mm to allow for burr hole placement in bone and increased planned poly to an 11 mm to account for larger tibial cut. The femoral cut made had no issues and normal resection depth noted. The tibial burr holes made with burr without issue, twin peg guide placed into burr holes and attempted to be verified with verification plate varus/valgus correct but system indicated that the slope was out by 13 degrees too much posterior slope, checkpoint verified and found to be correct. Numerous attempts made to verify the correct position of cut block. However, the navio tibial cut was abandoned and changed to manual instruments, made with extra medullary jig, attempted, tibial off cut was measured and well within specs, 9mm off lateral side and 7mm medial side. The case proceeded to trialing ps implants used, but the joint was found to be unstable. The poly increased sequentially until 18 mm stable in extension but still loose medially in high flexion. This caused a delay greater than 30 minutes.
 
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Brand NameNAVIO SURGICAL SYSTEM AU
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
rick confer
2828 liberty avenue
suite 100, PA 15222
4126833844
MDR Report Key10383293
MDR Text Key202170318
Report Number3010266064-2020-01704
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberNPFS02070
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2021
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: 08/09/2020 Patient Sequence Number: 1
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