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

Catalog Number NPFS02000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 02/05/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).Article cite: initial safety profile assessment of the navio robotic-assisted total knee arthroplasty, (b)(4), october 2019.Part 1 of 2.

Event Description

On the literature review " initial safety profile assessment of the navio robotic-assisted total knee arthroplasty ", it was reported that, after undergoing a navio-assisted ra-tka procedure, one (1) patient experienced deep infection.It is unknown how this adverse event was treated.No further information is available.

Manufacturer Narrative

H3, h6: the navio surgical system us, part number npfs02000, used for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.The clinical/medical investigation concluded that without the requested medical documentation, definitive clinical factors which could have contributed to the reported event could not be concluded.A complaint history review for similar reported/confirmed complaints has identified prior events.While all products meet required manufacturing specifications prior to release a serial number, lot number, part revision or software version is required to link the device to a dhr or nc investigation.As with any surgical procedure, there is risk involved.Potential complications accompanying surgery may occur, including: allergic reaction (anaphylactic and minor), infection, mild to serious physical injury, localized static shock, delay in the operation, surgical site nerve injury, vascular injuries of the lower extremity, soft tissue damage, major bone gouging at the surgical site, bone fracture, immature implant failure, unstable knee joint, limited or restricted knee range of motion, major blunt impact injury, unintended laceration/puncture wound, and osteonecrosis.This failure mode and associated risk could be a potential factor for the reported event and the documented risk level is still within the product risk profile.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with instruments not sterile after proper cleaning and sterilization.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 SURGICAL SYSTEM US
• Type of Device: 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: 15250870
• MDR Text Key: 298147889
• Report Number: 3010266064-2022-00567
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 885556628416
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention