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

Model Number	PFSD01008
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bone screw was found deformed.As this was noticed upon inspection, no case was involved.
Additional Manufacturer Narrative
The devices, used for treatment, were returned for prior evaluation.Visual inspection revealed that the bone pin had damaged threads.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
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10000386
• Report Number: 3010266064-2020-01537
• Device Sequence Number: 2208571
• Product Code: OLO
• UDI-Device Identifier: 00885556628737
• UDI-Public: 00885556628737
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/24/2019
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1