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

Catalog Number	NPFS02000
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that while preparing for a navio assisted tka surgery, the navio surgical system us booted up as expected but, when the attempt was made to home the bur they received a message saying "internal cabling/drill console error".After they rebooted, they got an error message came up saying "pfs control hardware failure".They shut down the machine, unplugged everything and rebooted, but the same error message came up before the start screen would appear therefore forbidding them from entering a case.Another reboot was attempted with the same error message.The procedure was completed with manual instrumentation without significant delays.The patient was not harmed beyond the reported problem.Additionally, they left the navio plugged in for 15 minutes and tried starting it up but the same message came up, forbidding them from entering the system.
Additional Manufacturer Narrative
Section d10 and g4 were updated.Section h10: the navio siu, intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.The sui was connected into a navio system.The 4000000000 error presented during the boot process.The siu was opened and it was confirmed that the f1 fuse is blown.The most likely cause of this event is a short in the internal wiring of the handpiece cable that was used during the case blowing the internal fuse on the siu motherboard.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.A historical escalation event review was completed.The review determined that prior escalation actions are applicable to the scope of this complaint however no further escalation action is required.The surgical technique guide provides guidelines for recovering to a fully manual procedure in the ¿recovery procedure guidelines¿.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.As a part of corrective action a more robust design of the siu has been released that will allow the fuse on the motherboard to be reset by cycling the siu power.The failure mode will continue to be monitored through complaint investigation and trended through post market surveillance (b)(4).

• Brand Name: NAVIO SURGICAL SYSTEM US
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13365079
• Report Number: 3010266064-2022-00056
• Device Sequence Number: 5235667
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 885556628416
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 200029, ISOLATION TRANSFORMER/UPS, U.S.; 220025, ASSY, PRGMMED, SIU, NAVIO, SERIAL (B)(6).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown