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

Model Number	PFSD01009
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before surgery, it was found that the tip of navio checkpoint verification was bending and broken.No patient involved.
Additional Manufacturer Narrative
The device was intended to be used during treatment and was returned for evaluation.The lot number for the device was not provided.However, all lots of pn 110198 distributed to the field from when the part number was first inspected to the complaint occurrence date were reviewed and there were no nonconformances found.There are no other issues that would potentially lead to a future performance issue.Therefore, the reported product met manufacturing specifications prior to being released for distribution.A complaint history review was performed and found 3 reports of the issue and will continue to be monitored.A relationship between the device and the reported event could not be established.The evaluation was performed on the checkpoint pin and it found it was not bent.Therefore the issue we cannot confirm the reported event.Therefore, the root cause of the reported event could not be determined.

• 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
• MDR Report Key: 9990534
• Report Number: 3010266064-2020-01241
• Device Sequence Number: 17068657
• Product Code: OLO
• UDI-Device Identifier: 00885556628720
• UDI-Public: 00885556628720
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/13/2020

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: PFSD01009
• Device Catalogue Number: PFSD01009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2019
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 08/13/2020
• Patient Sequence Number: 1