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

Catalog Number ROB00079

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

Patient Problems Deformity/ Disfigurement (2360); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2021

Event Type  Injury  

Event Description

It was reported that after navio tka procedure while viewing post-op x-ray, the implant presented severe valgus, despite navio said it was 0 degrees on post-op gap assessment. When reviewing the log files, something weird was found with collecting med/lat malleoli points. With case visualizer, lateral malleoli point in right next to tibial centre. It seemed the mechanical axis had collected totally wrong way. They tried to recreate the same situation of the case, but navio does not allow user to proceed with collecting wrong malleoli points. A warning kept appearing on neutral position collection step with wrong malleoli points.

• 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: 11617632
• MDR Text Key: 243903276
• Report Number: 3010266064-2021-00264
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/11/2021

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

• Device Catalogue Number: ROB00079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/05/2021
• 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

Patient Treatment Data

Date Received: 04/06/2021 Patient Sequence Number: 1