MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW NAVIO; STEROTAXIC INSTRUMENT, COMPUTER ASSISTED, PRODUCT CODE: OLO

Catalog Number PFSR015001

Device Problem Device Operational Issue (2914)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 04/02/2018

Event Type  malfunction  

Event Description

It was reported that the navio tissue protector was bent, so the cortical pins could not be introduced (bone pins stayed stuck inside the guide).The malfunction was able to be resolved by backing out the screw while still attached to the tissue protector.After removal of the screw, the case was completed utilizing backup equipment (surgical delay < 5 minutes).No patient injury or other complications were reported.

Manufacturer Narrative

Correction: b1, b2 and h1 were updated to report type adverse event.

Manufacturer Narrative

The navio soft tissue protector, (pn 101092), used in treatment was not returned for a prior investigation at the time of the occurrence.A relationship between the reported event and the device was established.A photo of the device from the prior investigation showed that the bone pin was stuck in the tissue protector.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.A complaint history review found similar reports, this issue will continue to be monitored.The surgical technique guide provides instructions for using the tissue protector.Specifically, the guide provides instruction on how to prepare the bone pin insertion location on the patient and how to insert the tissue protector within that location.The complaint does not suggest that the user deviated from these instructions.Moreover, as part of the functional evaluation in tr0979 that replicated the issue, the test operator followed the instructions provided in the surgical technique guide and experienced the bone pin getting stuck in the tissue protector.Accordingly, product labeling has been ruled out as a cause of the complaint.This failure is an identified failure mode within the risk file.Based on prior complaints received, it is likely that the event occurred due to the reported failure.The malfunction is due to a design issue due to the inner diameter of the tissue protector lumen diameter relative to the major diameter of the bone pin.Binding of the bone screw to the tissue protector is primarily due to tissue being wrapped around the threads.However, initial pin misalignment and bending of the pin are also contributing factors.Hhe-2020-12-pl and capa 200017 were opened as corrective actions to address this issue.As a result of the remedial investigation, we have thoroughly investigated the complaint per the criteria as required by 21 cfr 820.198(d).

• Brand Name: NAVIO
• Type of Device: STEROTAXIC INSTRUMENT, COMPUTER ASSISTED, PRODUCT CODE: OLO
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW; 2905 northwest blvd.; suite 40; plymouth MN 55441
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd; ste. 40; plymouth MN 55441
• Manufacturer Contact: richard confer ; 2828 liberty ave; suite 100; pittsburgh, PA 15222 ; 4126833844
• MDR Report Key: 7478491
• MDR Text Key: 107317899
• Report Number: 3010266064-2018-00005
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K160537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR015001
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1634-2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention