MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO BONE PIN; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number UNKNOWN

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 05/13/2019

Event Type  Injury  

Event Description

It was reported that during tka surgical procedure, the surgeon tried to remove tibial pin before taking off pin clamp and tracker, but there was a bent pin, which was removed after taking pin clamp and trackers off.There was not surgical delay caused by the reported event.Patient injuries were not reported.

Manufacturer Narrative

H11: correction: b1 and h1 were updated to report type adverse event.

• Brand Name: NAVIO BONE PIN
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth; minnesota, mn
• MDR Report Key: 9706210
• MDR Text Key: 187931597
• Report Number: 3010266064-2020-00035
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR