MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO TRACKER ARRAY CLAMP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ORPFSR110008

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 11/19/2019

Event Type  malfunction  

Event Description

It was reported that before procedure the tracker clamp will not open or close and it is considered inoperable.No patient involved.

Manufacturer Narrative

H10: this malfunction has not caused or contributed to a death or serious injury in the past; nor has a medical intervention been necessitated to preclude permanent impairment or, a body function or permanent damage to a body function.The manufacturer has identified that this event should be re-evaluated for mdr reporting.The re-assessment, based on analysis of historical data and risk management, determined that the issue does not meet the threshold for reporting and is a non-reportable event.

• Brand Name: NAVIO TRACKER ARRAY CLAMP
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 9998669
• MDR Text Key: 189446030
• Report Number: 3010266064-2020-01321
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628560
• UDI-Public: 00885556628560
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORPFSR110008
• Device Catalogue Number: ORPFSR110008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Date Manufacturer Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1