MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES SCREW, BONE, 4 MM OD X 5.0 (127 MM) IN LG, STRIDE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number NPFS02000

Device Problems Use of Device Problem (1670); Device Operational Issue (2914)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 11/09/2017

Event Type  Injury  

Event Description

It was reported that the bone pins were placed more distal in the femur due to a large nail in the patient's femur.As a result, while reaming for the box on the ps j2 femur, the surgeon hit the tip of a bone pin.After removing the pin, it was noticed that the tip of the pin had been reamed off.The tip of the pin could not be located so it is unknown if the material was retained in the surgical site.X-rays to be performed at the 6 week follow up visit.No injury or other complications reported at this time.

Manufacturer Narrative

Investigation narrative: the returned bone screw was evaluated and found that the most distal portion of the bone screw is missing.A measurement of the returned bone screw indicates that approximately.04" +/-.01" (1 mm) is missing.This indicates that the tip of the bone screw was most likely sawed off when performing the posterior cut of the tka procedure.The follow up visit included x-rays in which the surgeon and rep evaluated and found no foreign substance remaining in the patient.Given this information and the amount of bone screw that is unaccounted for, it is most likely that the portion of bone screw was irrigated out of the incision during surgery.The cause of this issue as detailed in the initial report was that the surgeon knowingly chose to move the bone screws more distal on the femur than recommended by the navio surgical technique guide to avoid a previous surgical nail.

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not 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 potential event described in this report.

Event Description

It was reported that due to a large nail in the patient's femur, bone pins had to be placed more distal in the femur.As a result, while reaming for the box on the ps j2 femur, the surgeon hit the tip of a bone pin.After removing the pin, it was noticed that the tip of the pin had been reamed off.The tip of the pin could not be found but x-rays taken 6 weeks post-op did not show any retained objects in the patient.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3, h6: the device, used for treatment, was returned for prior evaluation.Visual inspection of the returned material confirmed that the most distal portion of the bone screw was missing (approximately 1 mm in length).Review of x-rays provided by the site found no foreign substance remained in the patient.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 prior similar events.The navio surgical technique for tka (pn 500146 rev a) released at the time of the complaint states that the navio instrument kit consists of a two-level tray that contains the required instrumentation for any navio¿ surgical system tka procedure.The user's manual also includes instruction for proper bone tracker placement and use of the bone pins.The surgical technique also cautions: "warning: be sure to place the proximal bone pin as directed.If placed too close to the tibial plateau, it may interfere with placement of the tibial implant component, causing damage to the bone pin and possible patient harm".We were able to confirm there was a relationship established between the reported event and the device.The reported malfunction is likely due to the user knowingly choosing to place the bone pins more distal on the femur than recommended by the navio surgical technique guide to avoid a previous surgical nail.

• Brand Name: SCREW, BONE, 4 MM OD X 5.0 (127 MM) IN LG, STRIDE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest; blvd ste 40; plymouth, mn MN 55441
• MDR Report Key: 7101339
• MDR Text Key: 94518718
• Report Number: 3010266064-2017-00020
• 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,Followup,Followup
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NPFS02000
• Device Catalogue Number: PFSD101111
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR