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

Catalog Number PFSR110004

Device Problem Image Display Error/Artifact (1304)

Patient Problem Injury (2348)

Event Date 07/18/2018

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure, the surgeon burred the femur, finished in manual cut mode.He then refined the tibia and went to cut tibia still in manual control and there was a handpiece jam error.After multiple tried at troubleshooting they had to replace the handpiece, drill and long attachment.We were able to proceed with the case.No patient injuries reported beyond this event.Results of the investigation have concluded that the internal components of the handpiece motor have issues, which makes it a reportable event.

Manufacturer Narrative

The device was used during treatment and was returned for evaluation.The log files were returned for review and indicated that a jam detection occurred.When the handpiece was evaluated, there was wiring damage found.The dhr was reviewed and found that the product met manufacturing specifications prior to being released for distribution.A complaint history review found similar complaints of the reported issue and will continue to be monitored.The surgical technique guide released at the time of the complaint provides information for troubleshooting handpiece issues.This failure is an identified failure mode within the risk file.The relationship of the device and the reported event has been established.The log files indicated that a jam detection error had occurred, which was due to the motor cable damage.Therefore, the root cause of the reported event was raw material/supplier fault.

• Brand Name: NAVIO HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9997223
• MDR Text Key: 188886057
• Report Number: 3010266064-2020-00685
• 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: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR110004
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/18/2018
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 08/07/2020
• Supplement Dates FDA Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LONG ATTACHMENT; LONG ATTACHMENT
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 74 YR