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

Model Number PFSR110137

Device Problem Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 07/09/2019

Event Type  malfunction  

Event Description

It was reported that during setup for a tka while attempting to complete admin hand piece test the navio produced an error stating "cannot communicate with hand piece please be sure all cables are connected." sales rep attempted to run the hand piece test again and the same error was reported.Following the second error message the hand piece and anspach drill were unplugged and the test was attempted again with no success.The navio was then shut down rebooted.While the navio was rebooting the hand piece and anspach drill connector pins were checked and did not show signs of damage.Handpiece serial number (b)(4) was removed and a new navio tray was opened.The hand piece from the new tray was assembled and tested with no errors reported.Following the days cases sales rep tested hand piece (b)(4) on the navio at the phoenix lab and received no error messages.No patient involved.Investigation results determined that a connectivity issue at the handpiece end of the cable, the internal wiring at that end had come apart in the cable causing a short in the wiring, which is a reportable event.

Manufacturer Narrative

The navio handpiece, intended for use in treatment, was returned for further evaluation and a visual and functional inspection was performed, which confirmed the reported event.Visual inspection did not find any rips or tears in the cable of the handpiece, especially at the handpiece end.The strain relief was attached to the handpiece and not pulled away.During functional evaluation, the handpiece was connected to a system and the cable was manipulated during homing.The connection was intermittent and review of the log files on the system found that there was an over current error, confirming internal wiring damage.A device history record review found no conditions which could contribute to the reported event and the device met all manufacturing specifications during release for distribution.A complaint history review found 30 similar reports and this issue will continue to be monitored.The root cause was found to be electrical component failure.These results were indicative of a known issue and a corrective action has been requested for this issue.

• 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: 9998954
• MDR Text Key: 189335452
• Report Number: 3010266064-2020-01341
• 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: ORPFSR110137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 07/09/2019
• Supplement Dates FDA Received: 08/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1