MAUDE Adverse Event Report: SIGN FRACTURE CARE INTERNATIONAL SIGN FIN NAIL; INTRAMEDULLARY FIXATION ROD

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/21/2018

Event Type  Injury  

Manufacturer Narrative

A product investigation was performed for this device.The actual device was not returned to the manufacturer for evaluation.The root cause of the non-union and loosening is undetermined.The radiographic and clinical data were reviewed by a sign orthopedic surgeon.There is no way to predict a non-union or failure to heal.(b)(4) continues to monitor these events as part of our post market surveilance activities.

Event Description

We became aware on 12/22/2016 that a sign im nail implanted to repair a fracture was replaced due to a non-union and nail loosening.The im nail was replaced with a 10mm x 340mm fin nail per the sign technique manual.Surgeon comment: "(b)(6) has been having pain because the nail was protruding into the knee.We missed the slots in his first surgery.Today we removed the standard interlocking nail and replaced it with a fin nail because there was still motion at the fracture site.".

Event Description

We became aware on 2/27/2018 that a sign im nail implanted to repair a fracture was replaced due to knee pain and a non-union.The fin nail was replaced with a 10mm x 360mm standard nail per the sign technique manual.Surgeon comment: "(b)(6) was treated following his injury by a standard sign nail on (b)(6) 2015.As a result os continued pain at the knee and fracture site, he had exchange nailing with standard fin nail on (b)(6) 2016.He asked us to remove the fin nail about 3 months ago because he started having pain again.However, his fracture did not heal and so he had another thicker nail inserted antegrade today, plus bone graft.".

Manufacturer Narrative

A product investigation was performed for this device.The actual device was not returned to the manufacturer for evaluation.The root cause of the knee pain and non-union is undetermined.The radiographic and clinical data were reviewed by a sign orthopedic surgeon.This failure does not indicate a defect in the product.A minimal risk is associated with this failure.Sign fracture care international continues to monitor these events as part of our post market surveilance activities.The initial report was filed with patient id (b)(6).

• Brand Name: SIGN FIN NAIL
• Type of Device: INTRAMEDULLARY FIXATION ROD
• Manufacturer (Section D): SIGN FRACTURE CARE INTERNATIONAL; 451 hills street; suite b; richland, wa WA 99354 5502
• MDR Report Key: 6216448
• MDR Text Key: 63686771
• Report Number: 3034525-2016-00322
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K043200
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 31 YR
• Patient Weight: 79