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

Model Number ROB00004

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2019

Event Type  malfunction  

Event 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.

Manufacturer Narrative

H3, h6: the device was being used during treatment and was returned for evaluation.The plate probe fit over all of the handpieces without issue.The serial 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 (6/21/2019) 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 the reported event could be established.Functional evaluation of the plate probes found that they fit over the handpieces without any issues.There was no problem found.There is not enough information to determine factors that could have contributed to the reported issue.

Manufacturer Narrative

Additional info: g3 and attached memo.

• Brand Name: NAVIO TKA PLANE VISUALIZATION TOOL
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN
• MDR Report Key: 9999401
• MDR Text Key: 189163654
• Report Number: 3010266064-2020-01425
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556685068
• UDI-Public: 00885556685068
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ROB00004
• Device Catalogue Number: ROB00004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1