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

Catalog Number PFSR1101111

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/18/2016

Event Type  malfunction  

Event Description

It was reported that before a procedure, a bone pin was found bent.Pin was discarded by healthcare facility.Backup bone pins were available.

Manufacturer Narrative

H10 h3, h6: the device, used for treatment, was returned for evaluation.The field report noted that two bone pins were bent.The other bone pin was investigated under (b)(4).Visual inspection confirmed that the bone pin was bent on the threads about 1.2 inches from the bottom.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 13 prior similar events.This failure mode will be trended to assess for any necessary corrective actions.We were able to confirm there was a relationship established between the reported event and the device.The malfunction was likely due to mechanical component failure.Factors that could have contributed to the reported event include the user allowing the weight of the drill to fall as it is attached to the pin, if the bone pin is held rigidly in place during removal, or if the patient's bone is harder than normal.The navio system for unicondylar knee replacement user's manual provides detailed instructions for placing the bone pins and tracker arrays.The user is instructed to keep the drill in line with the pin when attaching/detaching.

• 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: 9989226
• MDR Text Key: 188674709
• Report Number: 3010266064-2020-00269
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR1101111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1