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 Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2018

Event Type  malfunction  

Event Description

It was reported that, during an tka surgery, the pin driver seemed to be stripped as it was not allowing to drill the bone pins in.The issue was resolved by using a back-up device.Surgery was delayed, but it is unknown for how long.The patient was not harmed.

Manufacturer Narrative

H10, h3, h6: the device, used for treatment, was returned for evaluation.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review identified similar events.Visual inspection of the returned pin driver found the inner portion would spin when it should have been fixed in place.The relationship of the subject device and reported event has been established.The broken pin driver was due to a mechanical component failure.Contributing factors related to a deficiency of the pin driver where the laser weld that attaches the outer tube to the inner cylinder with the triangular geometry fails, causing the outer tube to spin without spinning the screw.

• 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
• MDR Report Key: 9993663
• MDR Text Key: 190001436
• Report Number: 3010266064-2020-00798
• Device Sequence Number: 1
• Product Code: OLO
• 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
• Type of Report: Initial,Followup
• Report Date: 08/05/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: PFSR110164
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1