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

Catalog Number 110137

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2015

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure, the handpiece was able to pass the retract screen and calibration screen but an error message presented during homing.The physician tried to dismiss the error and home twice but both times an error presented again.The drill was removed from the handpiece and then reset it in to make sure it was locked into the handpiece.The gears were moved manually but they were stuck.The handpiece was replaced in order to complete the case.No surgical delay or patient injury was reported.Results of the investigation have concluded that the snaplock assembly was broken, which makes it a reportable event.

Manufacturer Narrative

The navio handpiece, used in treatment, would not home during a procedure.There was no impact on the case and there was an equipment swap to complete the case.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 similar reports.The navio handpiece was returned for further evaluation and the initial visual/functional inspection was performed, which did not confirm the reported event.This handpiece was found to have been in good working order and the reported problem could not be replicated.The root cause of this issue was found to be undetermined.

• Brand Name: HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd; suite 40; plymouth, mn
• MDR Report Key: 9996825
• MDR Text Key: 188889874
• Report Number: 3010266064-2020-00199
• 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
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

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 Catalogue Number: 110137
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/22/2015
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 08/03/2020
• Supplement Dates FDA Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 101209 (ANSPACH DRILL); 101209 (ANSPACH DRILL)