MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO CHECKPOINT VERIFICATION PINS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	PFSD01009
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during navio tka procedure while patient under anesthesia, during removal of checkpoint at end of surgery the pin broke in half.It is unknown how was the procedure completed.No delay, or patient harm reported.
Additional Manufacturer Narrative
The navio checkpoint verification pin, part pfsd01009 used for treatment was not made available to the designated complaint unit for evaluation thus, a visual and functional evaluation could not be performed.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, a contributing factor may be mechanical component failure.No containment or corrective actions are recommended at this time.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO CHECKPOINT VERIFICATION PINS
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10717926
• Report Number: 3010266064-2020-01932
• Device Sequence Number: 3141172
• Product Code: OLO
• UDI-Device Identifier: 00885556628720
• UDI-Public: 00885556628720
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: PFSD01009
• Device Catalogue Number: PFSD01009
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1