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

Model Number	PFSR110005
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pointer could only hardly be separated from the handpiece after registration.Surgery was completed with legion standard instrumentation.It is unknown if there was a delay or if there was patient impact.
Additional Manufacturer Narrative
Additional info: d10, d11, g4, g7, g9, h2, h3, h6, h10.Results of investigation: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional evaluation could not be performed.Dhr review found that the reported product met manufacturing specifications prior to being released for distribution.A complaint history review found similar reports, this issue will continue to be monitored.This failure is an identified failure mode within the risk file.The navio surgical technique guide released at the time of the complaint ((b)(4)) provides instructions for separating the handpiece from the point probe and for how to recover to a fully manual procedure in the case the of a navio surgical system failure at any point during the surgical case.A relationship, if any, between the subject device and the reported event could not be determined.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.No further medical assessment is warranted at this time.

• Brand Name: NAVIO POINT PROBE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 9991191
• Report Number: 3010266064-2020-01249
• Device Sequence Number: 11687480
• Product Code: OLO
• UDI-Device Identifier: 00885556628522
• UDI-Public: 00885556628522
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PFSR110005
• Device Catalogue Number: PFSR110005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 08/27/2020; 08/27/2020
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 08/31/2020; 02/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NPFS02020 NAVIO SURGICAL SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention