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

Model Number	PFSR110008
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during case had a tracker array move during a case 4.6 mm.The clamp used was brand new and moved 4.6 mm the next time it was used which was reported.The clamp was used on the tibia in this case, the em tibia jig was used to make tibia cut.No patient injury, outcome exactly as planned.Delay of less than 30 minutes was involved and no patient injuries were involved.
Additional Manufacturer Narrative
H10: the device was used in treatment.Case log files and screenshots were returned for evaluation.Device history record review found that the software version has been validated.A complaint history review found similar reports, this issue will continue to be monitored.This failure is an identified failure mode within the risk file.The navio system instructions for use released at the time of the complaint provides instructions for tracker placement, troubleshooting, and usage of the device.Review of the log files confirmed that the femur checkpoint failed verification after cutting the femur by 4.5mm.The femur checkpoint was then redefined.This value indicates that the femur tracker frame most likely moved from an edge to a flat during the case.While the tracker may seem tight and rigid even if it is tightened on an edge, it can still move to a flat during the case.The tracker could have rotated from the edge to the flat from the vibrations from burring the femur or the tracker could have been bumped slightly after the user finished cutting and switched to using the plate probe for visualize cut.Redefining the checkpoint does not realign the setup with the previous cut plan and should not be done unless it can be confirmed that neither tracker has moved.Therefore, if a tracker has moved, resetting the checkpoints is not the solution.If the checkpoints are reset for the femur, it is necessary to go through registration with the femur again (free collection, implant planning, refining, etc.).No further medical assessment is warranted at this time.

• Brand Name: NAVIO SURGICAL SYSTEM US
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 9999218
• Report Number: 3010266064-2020-01371
• Device Sequence Number: 19575241
• Product Code: OLO
• UDI-Device Identifier: 00885556628560
• UDI-Public: 00885556628560
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PFSR110008
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 04/25/2020
• Supplement Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention