MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES HANDPIECE, NAVIO (BBT HANDPIECE); ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number PFSR110137

Device Problems Failure to Recalibrate (1517); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 10/04/2017

Event Type  malfunction  

Event Description

It was reported that before the case, the handpiece was calibrated but it would not home.After attempting to move the gears manually and lubricating them, there was not possible to get the handpiece home.The handpiece was replaced in order to start with the case.The results of investigation indicate that the drill guide support is bent, which is a reportable malfunction.

Manufacturer Narrative

H10: the device, intended for use in treatment, was returned for investigation.The probable cause of the issue was a mechanical component failure.Dhr review found that no conditions that could contribute to the reported event were found.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.A relationship between the device and the reported event could be established.Visual inspection confirmed that there appeared to be damage to the drill guide support.Functional testing with a long attachment also indicated damage to the drill guide support and a functional homing test failed.Using a reduced long attachment (the barrel end was removed), the handpiece was able to home, confirming that the causes is a bent drill guide support.The malfunction is likely due to mechanical component failure from bending of the handpiece drill guide support.The material has been changed to stainless steel to increase durability and reduce deformation in the field.

• Brand Name: HANDPIECE, NAVIO (BBT HANDPIECE)
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd; suite 40; plymouth, mn
• MDR Report Key: 9994348
• MDR Text Key: 189492418
• Report Number: 3010266064-2020-00456
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was 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: Health Professional
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1