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

Catalog Number ROB00036

Device Problems Image Orientation Incorrect (1305); Intermittent Loss of Power (4016)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2019

Event Type  malfunction  

Event Description

It was reported that in ukr case, while collecting the hip center, the system rebooted abruptly. After rebooting, during the handpiece calibration stage, the system was not picking up on the points as quickly as it does normally. Changed the flat markers to eliminate that possibility but still faced the same problem. Only proceeded after calibrating the handpiece by moving it very slowly. The lag between the actual position of the handpiece and on screen display persisted during the cutting stages as well. At this point the handpiece was swapped, but the issue was not resolved.

• 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
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2828 liberty ave; suite 100; pittsburgh, pa
• Manufacturer Contact: richard confer ; 2828 liberty ave; suite 100; pittsburgh, pa ; 6833844
• MDR Report Key: 9994246
• MDR Text Key: 189308273
• Report Number: 3010266064-2020-01103
• Device Sequence Number: 1
• Product Code: OLO
• 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: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/05/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: ROB00036
• Was Device Available for Evaluation?: Yes

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse