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

Model Number PFSR110137

Device Problem Electrical Shorting (2926)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2019

Event Type  malfunction  

Event Description

It was reported that as soon as distal femur cutting started, handpiece homing and internal mechanical error presented.Calibration was done 3 times and passed once but homing failed.All internal connections were checked and failure continued.Handpiece was swapped with a different one to continue the case.Delay of less than 30 minutes was reported and no patient impact or injury was involved.Investigation results determined that connectivity issue at the handpiece end of the cable.The internal wiring at that end had come apart in the cable caused a short in the wiring, which makes it a reportable event.

Manufacturer Narrative

The navio handpiece, used 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, especially at the handpiece end.The strain relief was attached to the handpiece and not pulled away.During functional evaluation, the handpiece was connected to a system and the cable was manipulated during homing.The connection was intermittent and review of the log files on the system found that there was an over current error, confirming internal wiring damage.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 and this issue will continue to be monitored.The root cause was found to be electrical component failure.These results are indicative of a known issue and a 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: 9999510
• MDR Text Key: 189310211
• Report Number: 3010266064-2020-01477
• 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: 08/07/2020

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 Model Number: PFSR110137
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 04/26/2020
• Supplement Dates Manufacturer Received: 08/04/2020
• Supplement Dates FDA Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1