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 Known Impact Or Consequence To Patient (2692)
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
H10: the device was being used during treatment and was not returned for evaluation.The serial number for the device was not provided.However, all lots of (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 lots that had fit issues between the handpiece and the visualization tool.The affected lots were subsequently quarantined.It is likely that a few of the affected lots were released for distribution prior to the issue being detected in the field.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 not be established.A factor that could have contributed to the reported event was if the device had an incorrect notch curvatures that 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 returned device, this issue could not 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: 9999244
• Report Number: 3010266064-2020-01375
• Device Sequence Number: 19575244
• Product Code: OLO
• UDI-Device Identifier: 00885556685068
• UDI-Public: 00885556685068
• Combination Product (Y/N): N
• 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: 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: 06/21/2019
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 04/25/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention