MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SPEED CONTROL GUARD; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number PFSR100810

Device Problem Defective Component (2292)

Patient Problem Injury (2348)

Event Date 04/30/2018

Event Type  Injury  

Event Description

It was reported that during tka speed guard would not disengage handpiece to allow visualisation tool to be attached.Surgeon was completed as manual procedure.

Manufacturer Narrative

H3, h6: the device was used during treatment and was not returned for evaluation of the difficult disengagement of the speed guard.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.The failure has been identified in the risk file.The surgical technique guide released at the time of the complaint has recovery procedure guidelines in the case of a navio surgical system failure at any point during the surgical case.A failure can consist of, but is not limited to, a system software crash, unrecoverable hardware failure, handpiece failure with no back up available, tracker array failure or loss of contact with bone that is unrecoverable, etc (p.38).There is no indication that the instructions for use contributed to the reported event.The relationship of the device and the reported event has not been established.A factor that could have contributed to reported event was that the guards were sticking to the handpiece around the drill guide support.After cleaning and disinfecting the handpiece, the reportable was able to attach and detach the guards with no problem.However, without the actual device for evaluation, this is unable to be confirmed.Therefore, the root cause of the reported event could not be determined.

• Brand Name: NAVIO SPEED CONTROL GUARD
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9993601
• MDR Text Key: 188842973
• Report Number: 3010266064-2020-00613
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR100810
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1