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

Catalog Number ROB00079

Device Problems Defective Device (2588); Connection Problem (2900)

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

Event Date 07/19/2021

Event Type  Injury  

Event Description

It was reported that, during a navio-assisted tka surgery, a handpiece calibration error occurred.They swap the handpiece but the error still pops up.Therefore, the procedure was completed with manual instrumentation without significant delays.The patient was not harmed.Additionally, it was reported that when it was used with other system cart, it worked well.

Manufacturer Narrative

Results of investigation: the navio surgical system korea, part number rob00079, 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.Log files although submitted would have no information to add to the investigation.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.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.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.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 loose handpiece/point probe connection.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.Corrected data: h3, h6 (medical device problem code).

• Brand Name: NAVIO SURGICAL SYSTEM KOREA
• 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: 12271322
• MDR Text Key: 264942046
• Report Number: 3010266064-2021-00581
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556725597
• UDI-Public: 885556725597
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

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: ROB00079
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/03/2021
• Supplement Dates Manufacturer Received: 08/21/2022
• Supplement Dates FDA Received: 08/22/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention