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

Catalog Number PFSR110137

Device Problems Computer Software Problem (1112); Electrical Shorting (2926); Operating System Becomes Nonfunctional (2996)

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

Event Date 01/24/2020

Event Type  Injury  

Event Description

It was reported that during distal burring system crashed and displayed internal cabling/drill console error then would not start with error 4000000000.Replaced the internal 3 amp smd fuse and then replaced the siu to test and would not communicate with drill or handpiece in admin screen tests.Delay of less than 30 minutes and procedure was completed with s+n manual instrumentation.No patient injuries involved.

Manufacturer Narrative

H10: a1, h3: updated information.H11: b1, b2, d4, g3, g5, h1, h6: corrected information.

Manufacturer Narrative

H10: h3, h6: the device, used in treatment, was not returned for evaluation.Without the device being returned, the issue could not be confirmed.A relationship between the device and reported event has not been established and the root cause of the reported event could not be determined.There was no serial number noted in the initial investigation documents so we are unable to conduct a dhr review as a part of the investigation.A complaint history review was performed and found additional reports of the issue.The failure has been identified in the risk file.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.A failure can consist of, but is not limited, a system software crash, unrecoverable hardware failure, handpiece failure with no back available, tracker array failure or loss of contact with bone that is unrecoverable, etc.There is no indication in this complaint that the user did not follow the ifu.Our clinical assessment concluded: per complaint details, the device malfunction occurred during surgery but the procedure was changed to manual instrumentation to complete the surgery.Without the requested clinical information a thorough medical investigation cannot be rendered.A factor that could have contributed to the reported event could be a short in the internal cabling of the handpiece being used with the siu.No corrective action or containment is recommended at this time.This issue will continue to be monitored.

• Brand Name: NAVIO SURGICAL SYSTEM UK
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 9742950
• MDR Text Key: 187926931
• Report Number: 3010266064-2020-00052
• 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,Followup
• Report Date: 08/15/2020

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: PFSR110137
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 02/23/2020
• Supplement Dates Manufacturer Received: 04/23/2020; 08/06/2020
• Supplement Dates FDA Received: 04/27/2020; 08/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 220025 - SIU.
• Patient Outcome(s): Required Intervention