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 07/18/2019

Event Type  malfunction  

Event Description

It was reported that at the beginning of case, handpiece and drill were plugged in, pressed connect handpiece and error came up stating no handpiece was connected.User was able to dismiss error away.Then, it was switched from refine femur to burr femur, the handpiece motor control failure error came up.System was shut down and handpiece was swapped.Delay of less than 30 minutes was reported and no patient impact was involved.Investigation results determined the internal wiring at that end had come apart in the cable causing a short in the wiring of the handpiece, 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 by the strain relief.The strain relief was attached to the handpiece and not pulled away.There were no bent or damaged pins in the connector.During functional evaluation, the handpiece was connected to a system and originally connected without issue.A case was created and at the ¿handpiece connection¿ screen, the cable was bent so that it showed as disconnected.Review of the log files on the system showed an overcurrent error.Overcurrent errors indicate that the internal wiring at the handpiece end has come apart in the cable, causing a short in the wiring and an overcurrent error.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 31 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: 9999507
• MDR Text Key: 189309997
• Report Number: 3010266064-2020-01475
• 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: 08/09/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1