MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES UNKN NAVIO ROBOTICS INSTR; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number UNKN06100502

Device Problems Electrical /Electronic Property Problem (1198); Computer Operating System Problem (2898)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2020

Event Type  malfunction  

Event Description

It was reported that while testing the computer it was found that it was not getting bootup.No video on screen.They tried resetting all connections on cpu, monitor.They reset the cpu, but still not getting bootup.It is unknown whether the event happened during surgery and if there was patient involvement.

Event Description

It was reported that while testing the computer during setup for a navio sawbone demo, it was found that it was not getting bootup.No video on screen.They tried resetting all connections on cpu, monitor.They reset the cpu, but still not getting bootup.No patient involved.No other complications were reported.

Manufacturer Narrative

H3, h6: the product, unknown navio robotics instrument, unkn06100502, intended for use in treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be determined.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.Although the reported problem was not confirmed, factors that may have contributed to the reported symptom may have been associated with a loose cpu.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

• Brand Name: UNKN NAVIO ROBOTICS INSTR
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10135931
• MDR Text Key: 194615749
• Report Number: 3010266064-2020-01597
• 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: 09/28/2021

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 Catalogue Number: UNKN06100502
• Initial Date Manufacturer Received: 05/16/2020
• Initial Date FDA Received: 06/09/2020
• Supplement Dates Manufacturer Received: 09/28/2021
• Supplement Dates FDA Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NPFS02000, SERIAL: (B)(6).