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

Catalog Number PFSR110004

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2018

Event Type  malfunction  

Event Description

It was reported that the handpiece failed to home, the device was taken apart to check that the gears were not obstructed.The handpiece was re-homing but it failed again.The device was replaced to start with the case.The device was not being used with a patient during the event.Results of the investigation have concluded that the snaplock assembly was bent through force applied by the user.

Manufacturer Narrative

H10: h3, h6: the navio handpiece, intended for use in treatment, had homing failures and gears were not obstructed prior to a procedure.The navio handpiece was returned for further evaluation and the initial visual/functional inspection was performed, which was unable to confirm the reported event.The handpiece homed successfully and handpiece characterization resulted in acceptable t1 max torque value.It was autoclaved and cooled to try to replicate the result, and the same acceptable t1 max torque value was the result.The result was the same with a drill.Further inspection identified that the snap lock was bent and this was switched with a working one.The characterization resulted with an acceptable t1 max torque value again.The lead screw nut was most likely bent in the field.The returned handpiece did show some damage around the gear, further confirming that it was bent through force.The root cause of this issue was found to be user error.A device history record review found the device met all manufacturing specifications during release for distribution.A complaint history review found similar reports.

• Brand Name: NAVIO HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9993607
• MDR Text Key: 190017191
• Report Number: 3010266064-2020-00630
• Device Sequence Number: 1
• Product Code: OLO
• 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: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR110004
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1