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

Catalog Number ROB00043

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

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

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case- (b)(4).Initial reporter postal code (b)(6).

Event Description

It was reported that, during tibial morphing in a navio assisted tka surgery, the morphing image was suddenly completed even though the surgeon did not collect enough data to create the image.The surgeon continued to collect data after the issue occurred, the morphing image was modified to be in line with the collect data.After the morphing malfunction occurred, the surgeon continued the procedure with the faulty device, then, the checkpoint verification step did not appeared.The procedure was completed with a delay of less than 30 minutes, using the same device.The patient outcome is unknown.

Manufacturer Narrative

H3, h6: the navio surgical system japan, part number rob00043, serial (b)(6) and used for treatment, was not returned for evaluation.A relationship between the reported event and the device was established.A visual/functional inspection cannot be completed as no device was returned for evaluation.Supplemental file review: complete generation of tibia model: review of the patient case screenshots confirms the reported allegation of complete generation of the tibia model after only a few points collected.Checkpoint verification not prompted prior to femoral cut stage: review of the patient case screenshots confirms that the checkpoint verification screen did not show up right before the femoral cut stage of the case.The screenshots indicate that the user selected the checkpoint verification widget at the top left of the navio case after mapping the tibia and femur.This selection was also confirmed in the navio log.After verifying the checkpoints, the user went through the implant planning stage which was immediately followed by the femoral cut stage.Functional assessment of customer complaint using known good navio system: in regards to the reported allegation of absent checkpoint verification screen prior to femoral cut stage, the sequence of events associated with this case were duplicated using a known good navio system.After the mapping of the femur and tibia, the checkpoint verification widget was selected to verify checkpoints.After verification and the implant planning stage, the system immediately proceeded to the femoral cut stage of the case.Based on the above test and findings from the patient logs, it can be determined that if the user verifies the checkpoints prior to femoral cut stage, the system will not prompt the user to verify the checkpoints once he/she reaches the femoral cut stage.The test and findings from the patient log do not indicate a system failure.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.The root cause for the system failure of auto generation of tibia model is yet to be determined.This failure is being investigated as a system bug.Root cause is yet to be determined for this failure.As discussed above, the reported problem of absent checkpoint verification prompt error is not indicative of a system failure, therefore no cause needs to be determined.This scenario happens when user verifies the checkpoints prior to femoral cut stage, then the system will not prompt the user to verify the checkpoints once he/she reaches the femoral cut stage.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.".

• Brand Name: NAVIO SURGICAL SYSTEM JAPAN
• 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: 12697627
• MDR Text Key: 278372449
• Report Number: 3010266064-2021-00728
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556693667
• UDI-Public: 885556693667
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB00043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1