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

Catalog Number NPFS02000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/21/2020

Event Type  Injury  

Event Description

It was reported that, during a navio tka procedure, when using the visualization disk they noticed the femur cut block seemed too anterior that they would not be cutting any bone.They thought they had sized the femur too large (size 7) so they went back and planned for a size 6.This still seemed anterior.They then checked checkpoints and the femur array was off by 5.4 mm.They redefined the femur checkpoint and cut the tibia since that array hadn't moved.Then manually placed the 5-in-1 cut block for the femur.The surgeon insists that the femur array did not actually move and said it was locked on very tight and he could not physically move it (from what was witnessed, the surgeon pulled on the entire femur array multiple times to move the patients leg.While the array was secured tightly on the bone pins, he was cautioned that the pins may have become loose/moved in the femur).So, in summary, it was used navio for tibia and distal femur resection, then manual instrumentation to set femur cut block and check gaps.There was a delay of fewer than 30 minutes.The surgeon was pleased with the results; gaps were perfectly balanced.No other complications were reported.

Manufacturer Narrative

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.A screenshot review was completed and confirmed that the navio had planned for a size 7 femur, as well as the checkpoint verification error.Further review of the screenshots found that the initial femur cuts were completed for a size 7.The user later went back into the implant planning stage and changed the femur to a size 6.After this planning change, the user went to verify the checkpoints where the femur checkpoint failed by a distance of 5.2 mm, and then a second time by 220.8 mm.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports, this issue will continue to be monitored.No further medical assessment is warranted at this time.This situation was captured in the navio risk assessment released at the time of the complaint.The most likely cause of the reported issue is the moved femur checkpoint.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.Detailed instructions for placing the bone pins and tracker arrays is provided in the surgical technique guide.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.No corrective action or containment is recommended at this time.

Manufacturer Narrative

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.The navio surgical system log files and/or case files were not provided to the designated complaint unit for evaluation.Therefore visual and functional inspections could not be performed, and an assessment of the log files and/or case files could not be performed.The reported problem could not be confirmed.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports, this issue will continue to be monitored.No further medical assessment is warranted at this time.This situation was captured in the navio risk assessment released at the time of the complaint.Although the reported problem could not be confirmed, a contributing factor could have been the moved femur checkpoint.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.Detailed instructions for placing the bone pins and tracker arrays is provided in the surgical technique guide.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.No corrective action or containment is recommended at this time.If the log files or case screenshots are returned, the complaint will be re-investigated.

• 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
• MDR Report Key: 11144542
• MDR Text Key: 226000357
• Report Number: 3010266064-2021-00027
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 885556628416
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention