MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES, INC. NAVIO SURGICAL SYSTEM

Catalog Number NPFS02000

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 12/29/2016

Event Type  Injury  

Manufacturer Narrative

Smith & nephew has re-assessed this complaint in accordance to the provisions of 21 c.F.R.§803.50 and deemed this event reportable as a mdr reportable event.We are submitting one (1) initial, 30 day report, medwatch fda form 3500a.

Event Description

A bone screw had become bound to the tissue protector cannula due to a small amount of soft tissue being pulled into the tissue protector during placement of the bone screw on the tibia.To correct the problem the surgeon used a reciprocating saw to cut one cannula off and was then able to twist out the second screw and cannula, releasing the device with no parts left behind in the patient.This correction resulted in a few minutes delay in the procedure and no permanent impairment of a body function or structure, hence no serious injury.The surgeon was able to complete the case using a backup device.

Manufacturer Narrative

Smith & nephew has re-assessed this complaint in accordance to the provisions of 21 c.F.R.§803.50 and deemed this event reportable as a mdr reportable event.We are submitting one (1) initial, 30 day report, medwatch fda form 3500a.Disclaimer: smith & nephew is submitting the above report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.The report is based upon information obtained by smith & nephew, which the company may not have been able to investigate or verify prior to the date the report was required by fda.This report does not constitute an admission that the device, smith & nephew, or its employees, caused or contributed to the event described in this report.Nor does this report reflect a conclusion by fda, smith & nephew or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the event described in this report.Correction: b1 and h1 were updated to report type adverse event.Correction.B5 was updated.

Event Description

It was reported that during a surgical procedure, a bone screw had become bound to the tissue protector cannula due to a small amount of soft tissue being pulled into the tissue protector during placement of the bone screw on the tibia.To correct the problem the surgeon used a reciprocating saw to cut one cannula off and was then able to twist out the second screw and cannula, releasing the device with no parts left behind in the patient.This correction resulted in a few minutes delay in the procedure.The surgeon was able to complete the case using a backup device.

Manufacturer Narrative

The device, used in treatment, was returned for a prior investigation and was discarded.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 released at the time of the complaint provides instructions for using the tissue protector.Specifically, the guide does provide 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 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.We could not confirm if there was a relationship established between the reported event and the device.Photos of the device were not provided for evaluation and the device was discarded after a prior investigation.However, 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.

• Brand Name: NAVIO SURGICAL SYSTEM
• Type of Device: NAVIO SURGICAL SYSTEM
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES, INC.; 2905 northwest blvd.; ste. 40; plymouth MN 55441
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES, INC.; 2905 northwest blvd.; ste. 40; plymouth MN 55441
• Manufacturer Contact: richard confer ; 2828 liberty ave.; ste. 100; pittsburgh, PA 15222 ; 4126833844
• MDR Report Key: 6449688
• MDR Text Key: 71465127
• Report Number: 3010266064-2017-00003
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 03/31/2017
• Supplement Dates Manufacturer Received: 09/26/2022; 09/26/2022
• Supplement Dates FDA Received: 02/23/2020; 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1634-2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 161 KG