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

Catalog Number ROB00036

Device Problem Battery Problem (2885)

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

Event Date 03/19/2021

Event Type  Injury  

Event Description

It was reported that during machine set up before a navio procedure, it was found that the battery was not charging.Despite the battery being replaced, the problem persisted.The ups is faulty.They decided to proceed with manual procedure.No other complications were reported.

Manufacturer Narrative

H3, h6: the navio surgical system, india, part rob00036, sn(b)(6) intended for use in treatment was not made available to the designated complaint unit 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 determined.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, a factor that may have contributed to the reported event may have been associated with a ups failure.The navio surgical technique guide (500197) provides instructions on how to revert to a manual case from a system failure.This failure is an identified failure mode within the risk assessment.Per complaint details from india, it was reported that during set up before a navio procedure, it was found that the battery was not charging.Despite the battery being replaced, the problem persisted.The ups is faulty.Based on the information provided, the case continued conventionally with manual instrumentation.No other complications were reported.Smith & nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received the complaint can be reopened.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 at a future date, this evaluation will be reopened for investigation.

• 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
• MDR Report Key: 11656361
• MDR Text Key: 245126212
• Report Number: 3010266064-2021-00281
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556693506
• UDI-Public: 885556693506
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ROB00036
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention