MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM BE/FR/DE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number NPFS02020

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

Patient Problems Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 04/04/2021

Event Type  Injury  

Event Description

It was reported that on literature review "improved sizing with image-based robotic-assisted system compared to image-free and conventional techniques in medial unicompartmental knee arthroplasty", ninety three (93) patients underwent a primary uka procedure assisted with a navio robotic surgical system where cemented journey ii uni implants were used.From these patients, a total of nineteen (19) patients had a femoral component undersizing diagnosis defined as a distance reduction between the cortex and the femoral implant edge greater than 3mm when compared with preoperative x-rays.These nineteen (19) patients included: two (2) patients with undersizing related to the anterior femur measured as the distance between the cortex and the anterior edge of the femoral component when assessed on an ap radiograph, seven (7) patients with undersizing related to the posterior femur measured as the distance between the cortex and the posterior edge of the femoral component when assessed on a ap radiograph and ten (10) patients with undersizing related to the posterior femoral offset restoration measured as the distance between the axis of the posterior cortex of the femoral diaphysis and the posterior part of the femoral condyle.No additional details were provided regarding the clinical symptoms experienced by each patient, if any.The outcome of all patients is unknown.No further information is available.

Manufacturer Narrative

Internal complaint reference (b)(4).Article cite: batailler, c., bordes, m., lording, t., nigues, a., servien, e., calliess, t., & lustig, s.(2021).Improved sizing with image-based robotic-assisted system compared to image-free and conventional techniques in medial unicompartmental knee arthroplasty.The bone & joint journal, 103-b(4), 610¿618.Https://doi.Org/10.1302/0301-620x.103b4.Bjj-2020-1453.R1.

Manufacturer Narrative

Section h10: the navio surgical system be/fr/de, part number npfs02020, 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 the author has provided radiological assessment of the imaging within the text; therefore, further analysis is not warranted.As of the date of this medical investigation, patient specific documentation has not been received; therefore, no clinical factors were concluded to have contributed to the reported events.The patient impact beyond the reported undersized femoral components could not be determined based on the limited information provided in the literature.No further medical assessment can be rendered at this time.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.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 incomplete points collection.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.Internal complaint reference number: (b)(4).

• Brand Name: NAVIO SURGICAL SYSTEM BE/FR/DE
• 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: 15251393
• MDR Text Key: 298152735
• Report Number: 3010266064-2022-00570
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

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: NPFS02020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 11/13/2022
• Supplement Dates FDA Received: 11/15/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention