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

Model Number PFSR110137

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2019

Event Type  malfunction  

Event Description

It was reported that during surgery, attempted handpiece test and gears sounded like they wanted to work but torque was at 98.Switched out handpieces and never was able to get the handpiece test to pass or to get through homing.All three handpieces were tried.System was shutdown and restarted and we were unable to get through homing still.No patient injuries reported.

Manufacturer Narrative

The reported navio handpiece, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional evaluation could not be performed.A device history record review was not performed since there was no part/serial/lot number provided and it could not be concluded if the device met the manufacturing specifications.A complaint history review found 30 similar reports and this issue will continue to be monitored.A relationship, if any, between the subject device and the reported event could not be determined.A factor that could have contributed to the reported event would be if the handpiece motor had seized after sterilization, causing the higher torque.No containment or corrective actions are recommended at this time.If the product associated with this event is returned 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: 10000403
• MDR Text Key: 188988045
• Report Number: 3010266064-2020-01544
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• 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: 08/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PFSR110137
• Device Catalogue Number: PFSR110137
• Initial Date Manufacturer Received: 12/30/2019
• Initial Date FDA Received: 04/27/2020
• Supplement Dates Manufacturer Received: 08/05/2020
• Supplement Dates FDA Received: 08/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1