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

Catalog Number ROB00036

Device Problem Intermittent Communication Failure (4038)

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

Event Date 03/12/2021

Event Type  Injury  

Event Description

It was reported that during machine setup before a navio procedure, it was found that the anspach footpedal is showing disconnected on the hardware setup screen.The connection was reset and the machine was rebooted - still the problem persisted.The surgery was done manually with conventional smith and nephew instrument set.No other complications were reported.

Manufacturer Narrative

H3, h6: the navio surgical system (india) product rob00036, (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 1 prior event.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptom may be associated with a connection failure.If a navio surgical system failure occurs at any point during the surgical case, the surgical technique guide provides a ¿recovery procedure guidelines¿ table for recovering to a fully manual procedure.This failure mode is identified in the risk profile.Per complaint details from india, it was reported that before a navio procedure, the anspach footpedal was showing disconnected on the setup screen.The connection was reset and the machine was rebooted, however the problem persisted.Based on the information provided, the surgery was done manually with a conventional smith + nephew instrument set.No patient injury, impact or complications were reported.Smith & nephew has not received adequate materials (operative reports) to fully evaluation 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.

Manufacturer Narrative

H3, h6: the navio surgical system india, product rob00036, (b)(6) intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was established.The reported problem was visually confirmed.Two connectors are bent within the connector piece, preventing proper insertion of the piece into the siu.A functional evaluation could not be performed as the anspach connector piece could not be inserted into the siu.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 1 prior event.The most likely cause of this event is a connection failure due to damaged pins in the connector piece.A capa, hhe/pra, field action review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.If a navio surgical system failure occurs at any point during the surgical case, the surgical technique guide provides a ¿recovery procedure guidelines¿ table for recovering to a fully manual procedure.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details from india, it was reported that before a navio procedure, the anspach footpedal was showing disconnected on the setup screen.The connection was reset and the machine was rebooted, however the problem persisted.Based on the information provided, the surgery was done manually with a conventional smith + nephew instrument set.No patient injury, impact or complications were reported.Smith & nephew has not received adequate materials (operative reports) to fully evaluation 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.

• 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: 11617631
• MDR Text Key: 243903274
• Report Number: 3010266064-2021-00263
• 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: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other