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

Catalog Number 220025

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem Missing Value Reason (3192)

Event Date 04/18/2017

Event Type  Injury  

Event Description

It was reported that during case, left the planning stage, and about to begin burring, received an error "internal cabling/drill console error".After rebooting, received pfs error 40000000000.After swapping usb cables with siu and ups, after moving between cpu usb ports still same pfs error during boot up.Case was aborted and completed as a manual procedure.

Manufacturer Narrative

H10: h3, h6: the device, used during treatment, was returned for a prior investigation.The functional investigation found that the returned siu would not turn on when connected to power and switched to "on" due to a blown f1 fuse.The inspection procedure document was reviewed for the device at the time of manufacturing and passed all tests.Therefore, the reported product met manufacturing specifications prior to be released for distribution.A complaint history review found similar reports of the issue.This issue will continue to be monitored.The surgical technique guide released at the time of the complaint provides instructions on how to recover to a fully manual procedure in the case the of a navio surgical system failure at any point during the surgical case.This is an identified failure mode within the risk assessment.The relationship of the device and the reported event has been established.The error message was caused by a blown fuse in the siu.The root cause of the reported event was due to an electrical component failure.

• Brand Name: SIU
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9993829
• MDR Text Key: 189344488
• Report Number: 3010266064-2020-00492
• 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: 08/24/2020

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: 220025
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other