MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM INDIA; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number ROB00036

Device Problems Image Orientation Incorrect (1305); Intermittent Loss of Power (4016)

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

Event Date 02/09/2019

Event Type  malfunction  

Event Description

It was reported that in ukr case, while collecting the hip center, the system rebooted abruptly.After rebooting, during the handpiece calibration stage, the system was not picking up on the points as quickly as it does normally.Changed the flat markers to eliminate that possibility but still faced the same problem.Only proceeded after calibrating the handpiece by moving it very slowly.The lag between the actual position of the handpiece and on screen display persisted during the cutting stages as well.At this point the handpiece was swapped, but the issue was not resolved.

Manufacturer Narrative

H10, h3, h6: the device was being used during treatment when the software crashed after collecting hip center.The log files were returned for evaluation.The dhr was reviewed for software version (rc-6103) and it has been validated.A complaint history review found similar complaints of the reported issues.The relationship of the device and the reported event has been established.The system crashed when transitioning collect neutral position to stressed rom collection.Therefore, the root cause of the issue was due to software failure.

• Brand Name: NAVIO SURGICAL SYSTEM INDIA
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9994246
• MDR Text Key: 189308273
• Report Number: 3010266064-2020-01103
• 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: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB00036
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1