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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Post Operative Wound Infection (2446); Limb Fracture (4518)

Event Date 03/10/2021

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 is undetermined.There is no way to predict a non-union or failure to heal.The root cause of the infection is undetermined.Infections have many causes and treatments.Each infection is addressed individually and taken very seriously by both the attending surgeon and sign surgeons at sign headquarters.The radiographic and clinical data were reviewed by a sign orthopedic surgeon.This failure does not indicate a defect in the product.The risk associated was evaluated during the risk management process and was deemed an acceptable level of risk to the patient.Sign fracture care international continues to monitor these events as part of our post market surveillance activities.

Event Description

We became aware on 5/13/2021 that a sign im nail implanted to repair a fracture was replaced due to a non-union with infection.The im nail was replaced with a 9mm x 400mm standard im nail per the sign technique manual.Surgeon comment: "re-admission for dbr and exchange nail due to sis infection.".

• Brand Name: SIGN IM NAIL
• Type of Device: INTRAMEDULLARY FIXATION ROD
• Manufacturer (Section D): SIGN FRACTURE CARE INTERNATIONAL; 451 hills street; suite b; richland WA 99354 5502
• Manufacturer (Section G): SIGN FRACTURE CARE INTERNATIONAL; 451 hills street; suite b; richland WA 99354 5502
• Manufacturer Contact: robert schmitt ; 451 hills street; suite b; richland, WA 99354-5502 ; 5093711107
• MDR Report Key: 11871379
• MDR Text Key: 252210878
• Report Number: 3034525-2021-00086
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GA
• PMA/PMN Number: K022632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2021
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 24 YR
• Patient Weight: 91