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 after the "freak out mode" test, the handpiece was found to be excessively hot, which makes it a reportable event.

Manufacturer Narrative

H10: the navio handpiece (part number 110137 / serial number (b)(6)), intended for use in treatment, had homing failures and gears were stuck prior to a procedure on (b)(6) 2015.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 no similar reports, as the 1 complaint in the review is this complaint, and this issue will continue to be monitored.The navio handpiece was returned for further evaluation and the initial visual/functional inspection was performed, which confirmed the reported event.The gears were unable to be turned manually and a characterization was performed to free the gears.Characterization failed due to excessive range.Detailed visual inspection during characterization found that there were not enough shims present with the snap lock assembly.The snap lock assembly was removed and the handpiece was characterized again (just to move the gears in another attempt to free it up enough to move by hand).After characterization, the handpiece gears were free enough to move by hand.The snap lock was then re-assembled with the correct number of shims and the handpiece characterized again, and passed without any problems.During the first two characterizations, the t1 max torque values exceeded the limit.The third characterization passed with the t1 max torque value within the limit.A fourth characterization was performed without a snap lock assembly to verify the t1 max torque and it failed.The conclusion is that there is a defect with the planetary gears internal to the motor assembly and will be returned to oem for further evaluation.The root cause of this issue was found to be supplier / raw material fault.No containment or corrective actions are recommended at this time.

• 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: 9996830
• MDR Text Key: 188889717
• Report Number: 3010266064-2020-00198
• 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: 07/31/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2015
• Initial Date Manufacturer Received: 04/22/2015
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 101209 (ANSPACH DRILL); 101209 (ANSPACH DRILL)