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

Catalog Number PFSR110137

Device Problem Defective Component (2292)

Patient Problem Injury (2348)

Event Date 11/27/2019

Event Type  Injury  

Event Description

It was reported that damage in the cabling in the handpiece causes to damage the siu.A reset was completed with repeating the failure message, so the case was aborted and the procedure was finished with manual instruments.Surgery was delayed by less than 30 min.The patient outcome is unknown.

Manufacturer Narrative

Additional info: d10, g4, g7, g9, h2, h3, h6, h10.Results of investigation: 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 2 similar reports and this issue will continue to be monitored.The navio surgical system user¿s manual (500196 rev.C) was reviewed and it provides instructions on performing general maintenance of cords and cables.Additionally, product labeling has been ruled out as an issue for this complaint.This failure is captured in the navio risk profile.No relevant clinical information was provided to perform a thorough medical investigation.However, per communications, damage in the cabling in the hand piece caused damage the siu.A reset with repeating the failure message, so the case was aborted.As a result, the procedure surgery completed with s&n manual instrumentation.There was a reported surgical delay of less than 30 min.The patient outcome is unknown.Should additional supporting clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.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 there was damage to the internal wiring of the handpiece that cause a fuse in the siu to blow.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: 9999521
• MDR Text Key: 189154825
• Report Number: 3010266064-2020-01484
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ROB00049 NAVIO SURGICAL SYSTEM UK, SN(B)(6).
• Patient Outcome(s): Other; Required Intervention