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

Model Number NONE

Device Problems Use of Device Problem (1670); Device Damaged Prior to Use (2284)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 10/05/2015

Event Type  Injury  

Manufacturer Narrative

This report will be amended upon completion of the report.

Event Description

Dr.Attempted to put a checkpoint pin into the femur and after a first attempt noticed the tip of the pin was broken off.Dr.Not sure whether the pin was broken at this point or if it had been done before insertion.

Manufacturer Narrative

After visual inspection, it was revealed that the end of the checkpoint was burred off.This is a result of the checkpoint being placed too closely to the cut surface.Based on the visual inspection, it is clear that the checkpoint used in this procedure was burred off in a previous case, as they had not yet begun bone removal when the broken checkpoint was noticed.The system performed as expected.The error was due to poor checkpoint placement by the surgeon.

• Brand Name: NAVIO SURGICAL SYSTEM
• Type of Device: ORTHOPEDIC STEROTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd; suite 40; plymouth MN 55441
• MDR Report Key: 5169744
• MDR Text Key: 29008339
• Report Number: 3010266064-2015-00003
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K143668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: NONE
• Device Catalogue Number: NPFS-02000
• Device Lot Number: NONE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2015
• Date Manufacturer Received: 10/05/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 68