MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO CAMERA CART; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	PFSR110001
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that, during set up for a navio assisted surgery, the navio camera cart did not show a notification for "connected" when the hardware component was connected.The procedure was completed with manual instrumentation without delays.The patient was not harmed.Additionally, after inspection of the device, it was found that there was a loose connection.They re-connected the device and it booted properly.
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that, during set up for a navio assisted surgery, the navio camera cart did not show a notification for "connected" when the hardware component was connected.The procedure was completed with manual instrumentation without delays.The patient was not harmed.Additionally, after inspection of the device, it was found that there was a loose connection.They re-connected the device and it booted properly.
Additional Manufacturer Narrative
H3, h6: the navio camera cart, part number pfsr110001, serial number (b)(6), intended for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.The navio surgical technique guide for knee arthroplasty (500197 rev c) 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.The risk level is still adequate.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with a cable/connector failure.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

• Brand Name: NAVIO CAMERA CART
• 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: 13536963
• Report Number: 3010266064-2022-00100
• Device Sequence Number: 17430317
• Product Code: OLO
• UDI-Device Identifier: 00885556628461
• UDI-Public: 885556628461
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2022

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: PFSR110001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 08/10/2022
• 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: ROB00043-NAVIO SURGICAL SYSTEM (B)(6)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown