MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO BONE PIN 4.0MMX152MM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB00031

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2020

Event Type  malfunction  

Event Description

It was reported that during a navio tka procedure, when drilling the box, the surgeon hit the femoral bone pin.This damaged the bone pin (bent) making it unusable (it was no longer required either).It did not negatively affect the case (there were no delays and no injuries).No other complications were reported.

Manufacturer Narrative

The navio bone pin, part rob00031, used for treatment was not made available to the designated complaint unit for evaluation thus, a visual and functional evaluation could not be performed.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, the most likely cause of this event is improper handling of the part.Based on the investigation, no further containment or corrective action is recommended or required at this time.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO BONE PIN 4.0MMX152MM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10680633
• MDR Text Key: 211501081
• Report Number: 3010266064-2020-01867
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556685310
• UDI-Public: 00885556685310
• 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
• Report Date: 06/10/2021

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
• Device Operator: Health Professional
• Device Model Number: ROB00031
• Device Catalogue Number: ROB00031
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 06/09/2021
• Supplement Dates FDA Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1