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

Model Number PFSR110137

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2019

Event Type  malfunction  

Event Description

It was reported that it was difficult to move gears and torque was at 66.No patient involved.

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.The drill guide support was not bent and was stainless steel.There were no bent or damaged pins in the connector.The reported issue was investigated through functional evaluation.During a functional evaluation, handpiece characterization was done twice and resulted in t1 max torque values of 46 and 18.The handpiece was then sterilized and cooled for a day to check for a known issue when the handpiece motor requires higher than normal torque to move after sterilization.After cooling, it was tested 3 times and resulted in values of 68, 18, and 14.A device history record review found no conditions which could contribute to the reported event and the device met all manufacturing specifications during the 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 a mechanical component failure.These results were indicative of the known issue and 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: 9999458
• MDR Text Key: 189159107
• Report Number: 3010266064-2020-01447
• 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: 08/06/2020

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PFSR110137
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1