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

Catalog Number UNKNOWN

Device Problem Defective Component (2292)

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

Event Date 11/21/2016

Event Type  malfunction  

Event Description

It was reported that during a case, when the pins for the arrays were being place, it was noticed one of the pins was bent. a backup pin was used instead in the procedure.No surgical delay or patient injury reported. .

Manufacturer Narrative

H10 h3, h6: the reported device, used for treatment, was returned to the designated complaint unit for independent evaluation.Visual inspection of the returned bone pin found that it was bent in a u-shape.It had what appeared to be impact damage on two threads in the middle of the bend.This bend shape and the damaged threads indicate that the screw was fixated at two points and struck in the middle.A review of the device history records (dhr) 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 1 prior similar event.This failure mode is identified within the risk assessment.The navio system for unicondylar knee replacement (ukr) user's manual released at the time of the complaint provides detailed instructions for placing the bone pins and tracker arrays.The user is instructed to instructed to keep the drill in line with the pin when attaching/detaching.The user's manual also states that the navio instrument kit consists of a two-level tray that contains the required instrumentation for the navio¿ system provides a full traditional surgical instrumentation tray for the chosen implant should be available during every system use to manually implant the prosthesis in the event of system failure.It is recommended that users have fully populated and sterilized backup trays on-site at the time of the operation in the event that any parts malfunction or become damaged during the procedure.A relationship, if any, between the subject device and the reported event could be determined.

• 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: 9989217
• MDR Text Key: 188644884
• Report Number: 3010266064-2020-00273
• 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: 08/27/2020

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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1