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

Model Number	ORPFSR110008
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before procedure the tracker clamp will not open or close and it is considered inoperable.No patient involved.
Additional 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
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 9998669
• Report Number: 3010266064-2020-01321
• Device Sequence Number: 2078372
• Product Code: OLO
• UDI-Device Identifier: 00885556628560
• UDI-Public: 00885556628560
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

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: ORPFSR110008
• Device Catalogue Number: ORPFSR110008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 04/24/2020
• Supplement Report FDA Received Date: 05/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1