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 Device Operates Differently Than Expected (2913); Device Operational Issue (2914); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 07/24/2017

Event Type  Injury  

Event Description

It was reported that the patient suffered a tibial fracture between the tibial bone pins.The surgeon stated that a "crack" was heard while drilling the bone pins in the tibia.The patient came in 2 weeks post-operatively complaining of pain in his calf.X-rays were taken that reveal a tibial pin site fracture.He was sent in for an ultrasound and it was found he has dvt also (debatably related).The patient has been kept on a walker longer, delaying his therapy and extending his recovery.

Manufacturer Narrative

Investigation narrative: as the issue was found 2 weeks post-op, the bone screws used at the time were not available for evaluation.However, the x-rays were made available for review.From the x-rays it was obvious that the bone screw location was on the tibial crest.From an article published in the journal of arthroplasty titled "pin site complications associated with computer-assisted navigation in hip and knee arthroplasty" (dated (b)(6) 2017) it was found that the rate of complications is very low but in the cases in which it arises, the majority are due to the proximity of the pins to the tibial crest.Therefore it is our conclusion that the cause of the fracture was due to the location of the pins on the tibia and not the diameter or geometry of the pins.

Event Description

It was reported that the patient suffered a tibial fracture between the tibial bone pins.The surgeon stated that a "crack" was heard while drilling the bone pins in the tibia.The patient came in 2 weeks post-operatively complaining of pain in his calf.X-rays were taken that reveal a tibial pin site fracture.He was sent in for an ultrasound and it was found he has dvt also (debatably related).The patient has been kept on a walker longer, delaying his therapy and extending his recovery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

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.

Manufacturer Narrative

H10, h3, h6: the device, used for treatment, was not returned for evaluation.Initial investigation results indicated that the user reported hearing a "crack" while drilling the bone pins in the tibia.A follow-up x-ray confirmed a tibial pin site fracture.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 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".This failure mode is identified within the risk assessment.We were able to confirm if there was a relationship established between the reported event and the device.The malfunction occurred intraprocedurally while the surgeon was drilling the bone pins in the tibia; however, the issue was discovered 2 weeks post-operatively.Review of the x-rays provided by the site revealed that the bone pin location was on the tibial crest which may have made the patient more susceptible to the injury due to the proximity of the bone pins to the tibial crest.The issue was due to user error of the placement of the bone pin.

• 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: 6809284
• MDR Text Key: 83193300
• Report Number: 3010266064-2017-00013
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NPFS02000
• Device Catalogue Number: PFSD101111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 08/21/2017
• Supplement Dates Manufacturer Received: 07/24/2017; 07/24/2017; 08/11/2020
• Supplement Dates FDA Received: 06/13/2018; 04/23/2020; 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 111