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

Model Number	PFSR110005
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/05/2019
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
Additional info: d10, d11, g4, g7, g9, h2, h3, h6, h10.Results of investigation: the device was being used.During treatment and was returned for evaluation.The functional inspection found that the plate probe could not be locked into the collet and was slightly tight when removing it.The dhr was reviewed for (b)(4) /lot c12834-2-1 and c13069-1-2 and found that they were related to an non conformance which was for 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 36 reports of the issue.This issue will continue to be monitored.A relationship between the device and reported event has 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.The reported event can be confirmed.Therefore, the root cause of the reported event was due to supplier/raw material fault.There has been a corrective action opened to address this issue and it is being further investigated.

• 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
• MDR Report Key: 9999141
• Report Number: 3010266064-2020-01353
• Device Sequence Number: 11371900
• Product Code: OLO
• UDI-Device Identifier: 00885556628522
• UDI-Public: 00885556628522
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/31/2020

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: PFSR110005
• Device Catalogue Number: ROB00004
• Device Lot Number: C13069-1-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NPFS02020 NAVIO SURGICAL SYSTEM.