MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES UNKN NAVIO ROBOTICS DEV; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number UNKN06100500

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

Patient Problem Loss of Range of Motion (2032)

Event Date 01/21/2021

Event Type  Injury  

Event Description

On the literature article named "initial experience with the navio robotic-assisted total knee replacement-coronal alignment accuracy and the learning curve.", it was reported that, after using the navio robotic-assisted system for tkr with legion prosthesis, 2 patients underwent an unspecified manipulation under anesthesia due to stiffness at 6 weeks postoperatively.The outcome of the patients is unknown.

Manufacturer Narrative

H3, h6: the product, unknown navio robotics device (australia), unkn06100500, sn unk used for treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be confirmed.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints has identified prior events.A historical capa, hhe/pra, field action review was not completed.The product was not returned and no evidence was made available to link the complaint to a capa, hhe/pra, field action.The cause of this adverse event is undeterminable.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.Arthrofibrosis is a well-known potential post-operative occurrence and does not support a component malperformance.Although the reported problem was not confirmed, factors that may have contributed to the reported symptom may have been associated with alignment, fit/size of device used or wear.The navio surgical system is a surgical tool designed to assist the surgeon; it is not a substitute for the surgeon¿s experience and skill.The surgeon retains all responsibility for the planning and the conduct of the surgery during which the navio surgical system is being used.The risk assessment notes the intended use, indication for use and design assumptions of the navio system.A clinical/medical evaluation was performed.Per the complaint details, the article reported that 6 weeks postop ras-tka, 2 patients required manipulation under anesthesia (mua) due to stiffness.Responses to the requests for clinical documentation was not provided as of the date of this medical investigation.Without patient-specific clinical information/documentation, further assessment of the reported stiffness and subsequent mua could not be performed.Stiffness and arthrosis are known potential post-tka complications for which mua is commonly performed; however, this does not support a mal-performance of the prosthetic components.The root cause beyond those reported in the article could not be confirmed or concluded and the current patient status remains unknown.The patient impact beyond the reported stiffness and subsequent mua could not be determined.The current patient status is unknown.No further medical assessment could be rendered at this time.Should clinically relevant documentation become available the medical investigation task may be re-evaluated.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

• Brand Name: UNKN NAVIO ROBOTICS DEV
• 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: 12142914
• MDR Text Key: 260711867
• Report Number: 3010266064-2021-00536
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN06100500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2021
• Initial Date FDA Received: 07/09/2021
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other