MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO BONE SCREW DRIVER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number PFSR110164

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2020

Event Type  malfunction  

Event Description

It was reported that during a tka procedure, the navio bone screw driver was stripped.The equipment was swapped to continue with the procedure without delays.This is the third of three screws.No other complications were reported.

Manufacturer Narrative

The pin driver, intended for use in treatment, was returned for investigation.Dhr review found that no conditions that could contribute to the reported event were found.The reported product met manufacturing specifications prior to being released for distribution.There were no indications of an issue that would potentially lead to a future performance issue.A complaint history review found similar reports, this issue will continue to be monitored.We were not able to confirm if there was a relationship established between the reported event and the device.Visual and functional evaluation found the pin drivers worked as expected and had no damage.No problem found with the pin drivers.A factor that could have contributed to the reported issue is if the pin driver was not properly put onto the bone screw, causing it to be loose and appear stripped.No correction or corrective actions required at this time.

• Brand Name: NAVIO BONE SCREW DRIVER
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10103303
• MDR Text Key: 193434755
• Report Number: 3010266064-2020-01588
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628614
• UDI-Public: 885556628614
• 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: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR110164
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1