MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO BONE PIN 4.0MM X 127MM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number PFSD01008

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 08/24/2019

Event Type  malfunction  

Event Description

It was reported that bone screw was found deformed.As this was noticed upon inspection, no case was involved.

Manufacturer Narrative

Memo for the submission added - attachment: [memo - mdr submissions.Pdf].

Manufacturer Narrative

The devices, used for treatment, were returned for prior evaluation.Visual inspection revealed that the bone pin had a dull tip.Functional inspection revealed one bone screw was bent (3.5 inches from tip).A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review identified prior similar events.We were able to confirm there was a relationship established between the reported event and the device.The malfunctions were likely due to mechanical component failure from bending of the bone screw, use of the bone pins over time, and clamping on the pins at the threads.

• Brand Name: NAVIO BONE PIN 4.0MM X 127MM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 9999766
• MDR Text Key: 189061217
• Report Number: 3010266064-2020-01519
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628737
• UDI-Public: 00885556628737
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PFSD01008
• Device Catalogue Number: PFSD01008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2020
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1