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

Model Number	ROB00004
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that plane visualization tool for needs to be replaced because they are all snug or get stuck when affixing them to the handpiece with the drill inserted.Drills need to be removed in order to properly attach.No patient involved.
Additional Manufacturer Narrative
The devices were being used during treatment and were returned for evaluation.The plate probes fit over all of the handpieces without issue.The serial number for the device was not provided.However, all lots of pn (b)(4).Distributed to the field from when the part number was first inspected ((b)(6)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.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.Functional evaluation of the plate probes found that they fit over the handpieces without any issues.A factor that could have contributed to the issue is if there was debris caught between the handpiece and visualization tool, preventing it from being fully locked in.However, there was no problem found.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: 9999433
• Report Number: 3010266064-2020-01433
• Device Sequence Number: 2968436
• Product Code: OLO
• UDI-Device Identifier: 00885556685068
• UDI-Public: 00885556685068
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 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: ROB00004
• Device Catalogue Number: ROB00004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 04/26/2020
• Supplement Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1