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	07/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during inspection, the plane verification tool from tka tray was difficult to slide and lock into the multiple navio handpieces.No case involved.
Additional Manufacturer Narrative
The device was being used during treatment and was returned for evaluation.The lot number for the device was not provided.However, all lots of pn 101425 distributed to the field from when the part number was first inspected (4/25/2016) to the complaint occurrence date ((b)(6) 2019) were reviewed finding one lot that was related to fit issues between the handpiece and the visualization tool.However, without the lot information, it cannot be determined if the reported product met manufacturing specifications prior to being released for distribution.A complaint history review was performed and found reports of the issue.This issue will continue to be monitored.A relationship between the device and the reported event could be established.The reported event was confirmed.There appeared to be a concentricity issue with the interior of the plate probe prohibiting it from sliding over the long attachment.Therefore, the root cause of the reported event was due to raw material fault/supplier.No containment or corrective actions are recommended at this time.

• 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: 9999466
• Report Number: 3010266064-2020-01454
• Device Sequence Number: 3159231
• Product Code: OLO
• UDI-Device Identifier: 00885556685068
• UDI-Public: 00885556685068
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2020

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: 13709
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 04/26/2020
• Supplement Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1