MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO HANDPIECE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number PFSDV0016

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2020

Event Type  malfunction  

Event Description

It was reported that during a navio tka procedure, when trying to bur the distal femur, the bur would not extend past the guard.There was over 2 mm of bone showing on the model.They tried checking to make sure the bur had not backed out, unplugged and plugged the bur back in, checked the checkpoints, re -calibrated, and changed the handpieces.The same issue continued to persist.Finally, it worked after going back into the planning screen and adjusting the distal to be 0.5 mm more and then moved it back to the original spot.When they got back to the cutting screen the bur worked.There was a delay greater than 30 minutes due to this issue.The patient outcome is unknown.

Manufacturer Narrative

H3, h6: the navio handpiece, part pfsr110137 used for treatment was not made available to the designated complaint unit for evaluation thus, a visual and functional evaluation could not be performed.While all products meet required manufacturing and service specifications prior to release, a serial number is required to complete a manufacturing and service dhr review.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, a contributing factor may be mechanical component failure.No containment or corrective actions are recommended at this time.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 HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10480786
• MDR Text Key: 205261199
• Report Number: 3010266064-2020-01740
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628904
• UDI-Public: 00885556628904
• 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
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PFSDV0016
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1