MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO TKA PLANE VISUALIZATION TOOL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	ROB00004
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that plate probes need to be replaced due to fit issues.No patient involved.
Additional Manufacturer Narrative
H3, h6: the device was being used during treatment and was returned for evaluation.The plate probe was tested and had no fit issues when connected to the handpiece, drill, or long attachment.There were also no visual issues that could have contributed to the reported event.Therefore, the reported event cannot be confirmed.A relationship between the device and reported event has not been established.There was no problem found.The dhr was reviewed and found that the lot had fit issues between the handpiece and visualization tool.There were no other issues that would potentially lead to a future performance issue.A complaint history review was performed and found additional reports of the issue.This issue will continue to be monitored.

• Brand Name: NAVIO TKA PLANE VISUALIZATION TOOL
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 9999292
• Report Number: 3010266064-2020-01398
• Device Sequence Number: 16933743
• Product Code: OLO
• UDI-Device Identifier: 00885556685068
• UDI-Public: 00885556685068
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

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: ROB00004
• Device Catalogue Number: ROB00004
• Device Lot Number: C12834-2-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 04/25/2020
• Supplement Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1