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.

• Brand Name: NAVIO HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: richard confer ; 2828 liberty ave; suite 100; pittsburgh, PA 15222 ; 7634524980
• MDR Report Key: 9998954
• MDR Text Key: 189335452
• Report Number: 3010266064-2020-01341
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/09/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PFSR110137
• Device Catalogue Number: ORPFSR110137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse