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

Catalog Number NPFS02000

Device Problem Application Program Problem: Parameter Calculation Error (1449)

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

Event Date 06/14/2021

Event Type  Injury  

Event Description

It was reported that, after a navio-assisted ukr surgery, the surgeon felt that the tibia cut ended up in varus after having used the navio bur in exposure mode.The only concern was how the tibia cut turned out.The procedure was completed without any delay, using the same device.

Event Description

It was reported that, after a navio-assisted ukr surgery, the surgeon felt that the tibia cut ended up in varus after having used the navio bur in exposure mode.The only concern was how the tibia cut turned out.The procedure was completed without any delay, using the same device.According to the last communication, patient was fine.

Manufacturer Narrative

Additional information: b5 h3, h6: the navio surgical system us, pn: npfs02000, sn: (b)(6) used in treatment was not returned to the designated complaint unit for evaluation, therefore visual and functional inspections could not be performed.The case files/log files were provided but were unable to be viewed.Multiple attempts were made to re-retrieve these files but was unsuccessful.Therefore the reported varus tibia cut could not be confirmed.Possible contributing factors that could have resulted in a varus tibia cut could be any or a combination of the following: 1.The user may not have removed possible osteophyte(s) prior to mapping the knee but removed prior to cutting.Therefore, during bone cutting,when the drill sweeps over the area where the osteophytes had been prior to removal, the virtual model would show an overcut.2.There may have been inadequate point collection of the tibia, where the virtual model is approximated as opposed to the actual mapped surface.The bur is going to extend to the depicted version of the bone model.Over-resection is possible if the bone model was approximated and under-sized if free collection was insufficient.3.Tibia bone tracker movement is possible and is evident when an entire area of the bone model shows 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.Prior to bone cutting, it is suggested to refine the bone model.For the removal of prominent spurs or osteophytes that could inhibit the leg motion, refer to the surgical technique guide for proper knee exposure and preparation.It is recommended that you trace the outline of the tibial surface first and then continue collecting points.The system updates continuously to fit the virtual bone surface to the green points as they are collected.Detailed instructions for placing the bone pins and tracker arrays is provided in the surgical technique guide.Checkpoint pins should be placed in both the femur and the tibia, in positions where they will not be disturbed during bone removal.The recommended position for the femoral checkpoint pin is in the medial or lateral femoral metaphysis.The recommended position for the tibial checkpoint pin is within the incision distal to the anticipated tibia cut.Refer to the user¿s manual for the placement of the bone tracker attachments.Rigid fixation of the femur and tibia tracking arrays into the bone is critical for a successful navio surgical system surgery.If it is suspected that a bone tracker array has moved during surgery, secure the tracker array and click on the appropriate icon to return to the checkpoint verification screen to re-collect and reverify the checkpoints.The clinical/medical evaluation concluded: ¿the requested medical documentation was not provided, therefore, the root cause could not be fully assessed or definitively concluded.The patient impact beyond the reported varus tibia cut could not be determined.Any product/engineering evaluation will be performed independent of the medical investigation.Should clinically relevant documentation/information become available and/or a product/engineering evaluation conclusion results in findings which are deemed clinically relevant, the clinical/medical task may be re-evaluated.No further medical assessment could be rendered at this time.¿ this situation is captured in the risk assessment released at the time of the complaint.The failure mode and associated risk have been anticipated within the risk file and that the documented risk level is still adequate.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports.A review of prior escalation actions was performed and found no actions that are applicable to the scope of the reporteld complaint.This issue will be continuously monitored through complaint investigation and post market surveillance.Based on the investigation, no containment or corrective actions are recommended at this time.

• Brand Name: NAVIO SURGICAL SYSTEM US
• 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: 12080987
• MDR Text Key: 259380270
• Report Number: 3010266064-2021-00492
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 885556628416
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Other