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

Model Number NPFS02000

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 09/30/2019

Event Type  Injury  

Event Description

It was reported that navio sized femur to size 8 and surgery was completed by downsizing and implanting a size 5 manually after cutting a size 6 with navio.Delay of less than 30 minutes reported and no injuries involved.

• Brand Name: NAVIO SURGICAL SYSTEM US
• 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; 2905 northwest blvd ste 40; plymouth MN
• Manufacturer Contact: rick confer ; 2828 liberty ave; suite 100; pittsburgh, PA 15222
• MDR Report Key: 9536921
• MDR Text Key: 182628135
• Report Number: 3010266064-2019-00153
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 00885556628416
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: NPFS02000
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 04/15/2021
• Supplement Dates FDA Received: 04/19/2021
• Was Device Evaluated by Manufacturer?: No
• 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