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

Model Number	ROB00004
Medical Device Problem Code	Mechanical Problem (1384)
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 a problem with the tool was found in the warehouse, the notches were preventing the plate probes from properly locking into the handpiece.No patient involved.
Additional Manufacturer Narrative
H10 attachment add: memo - mdr submissions.
Additional Manufacturer Narrative
The device was being used during treatment and was returned for evaluation.The functional inspection found that the plate probe locked into position when connected to handpiece without any problem.However, it appeared to have a concentricity issue with the interior of the plate probe prohibiting it from sliding over the long attachment.The dhr was reviewed for pn 101425/lot c12834-2-1 and found a lot that had fit-related 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 similar reports of the issue.This issue will continue to be monitored.A relationship between the device and reported event has been established.The functional evaluation confirmed that the device had an incorrect notch curvature.Plate probes from previous suppliers had different curvatures on the locking mechanism, which prevented the plate probe from fully locking in.It was found that these parts from previous suppliers were not machined with sufficient space to allow proper locking with the handpiece.The reported event can be confirmed.Therefore, the root cause of the reported event was due to supplier/raw material fault.

• 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: 9999475
• Report Number: 3010266064-2020-01457
• Device Sequence Number: 11588991
• Product Code: OLO
• UDI-Device Identifier: 00885556685068
• UDI-Public: 00885556685068
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 08/17/2020

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: C1283421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 07/17/2019; 08/11/2020
• Initial Report FDA Received Date: 04/26/2020
• Supplement Report FDA Received Date: 04/26/2020; 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1