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

Catalog Number ROB00036

Device Problem Interrogation Problem (4017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/04/2022

Event Type  Injury  

Event Description

It was reported that, during a navio assisted surgery, during femur cut stage of the surgery, the error e8 came on the anspach console.The procedure was completed with a delay of less than 30 minutes, with a change of technique to a manual procedure.The patient was not harmed beyond the reported problem.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6.The navio surgical system india, part number rob00036, serial number (b)(6), 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 device did not perform as intended during the ¿femur cut stage¿ of the surgery, and the navio system was abandoned.Per the field report form, the surgery was concluded using manual procedure with a 0-30 minute surgical extension without patient injury due to the reported event.Patient impact beyond the reported 0-30 minute surgical delay, abandoning the navio¿ system and subsequent use of manual instrumentation to perform the procedure would not be anticipated as manual procedure/standardized instrumentation is an approved surgical technique and no patient harm was alleged due to the reported event.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.If a navio surgical system failure occurs at any point during the surgical case, refer to the surgical technique guide for knee arthroplasty, recovery procedure guidelines tables for proper guidance regarding recovering to a fully manual procedure.A failure can consist of, but is not limited to, a system software crash, unrecoverable hardware failure, handpiece failure with no backup available, tracker array failure or loss of contact with bone that is unrecoverable, etc.The failure mode and associated risk have been anticipated within the risk file 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 a drill/handpiece issue.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 INDIA
• 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: 15090624
• MDR Text Key: 296460470
• Report Number: 3010266064-2022-00538
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556693506
• UDI-Public: 885556693506
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB00036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• 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
• Treatment: UNKN NAVIO ROBOTICS INSTR
• Patient Outcome(s): Required Intervention