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

Model Number	ROB00004
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the account received 3 additional visualization plane checker tools and none of them will lock on to handpieces.Scrub tech attempted all 3 new plane checkers and they almost fit but the collar would not seat down.Rep also tried outside of the sterile field.Navio tka back-up tray was opened, used a plane checker and it locked on with no problem on to the same handpiece.No patient involved since the event occurs before tka.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h3, h6: the device was being used during treatment and was not 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) 2020) 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 similar reports of the issue.This issue will continue to be monitored.A relationship between the device and reported event has not been established.Factors that could have contributed to the reported event is that the plate probe had an incorrect notch curvature.Therefore, this issue prevented the plate probe from fully locking in and it was not machined with sufficient space to allow proper locking with the handpiece.However, without the device for evaluation, the reported event cannot be confirmed.Therefore, the root cause of the reported event could not be determined.

• 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: 9999479
• Report Number: 3010266064-2020-01461
• Device Sequence Number: 19658956
• Product Code: OLO
• UDI-Device Identifier: 00885556685068
• UDI-Public: 00885556685068
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

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?: No
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 04/26/2020
• Supplement Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1