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

Catalog Number NPFS02020

Device Problem Application Program Problem: Parameter Calculation Error (1449)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2020

Event Type  Injury  

Event Description

It was reported that, on the literature review ""is robotic-assisted unicompartmental knee arthroplasty a safe procedure? a case control study"", four (4) uka procedures assisted with a blue belt navio robotic surgical system were aborted and completed with conventional instrumentation.One (1) of these cases was aborted because the femoral cut was inadequate with an error in the planning, which was adjusted with conventional cutting jigs.No further information is available.

Manufacturer Narrative

Internal complaint reference (b)(4).Article cite: mergenthaler, g., batailler, c., lording, t., servien, e., & lustig, s.(2021).Is robotic-assisted unicompartmental knee arthroplasty a safe procedure? a case control study.Knee surgery, sports traumatology, arthroscopy : official journal of the esska, 29(3), 931¿938.Https://doi.Org/10.1007/s00167-020-06051-z.

Manufacturer Narrative

Section h10: the navio surgical system be/fr/de, part number npfs02020, intended 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 there were no clinical factors found which would have contributed to the event.With the information provided, the patient impact beyond that which was reported cannot be determined.No further medical assessment can be rendered at this time.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.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.The navio surgical technique guide for knee arthroplasty 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 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: 15253410
• MDR Text Key: 298171424
• Report Number: 3010266064-2022-00574
• 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: 11/09/2022

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
• 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: 11/06/2022
• Supplement Dates FDA Received: 11/09/2022
• 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