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

Device Problem Break (1069)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/15/2018

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 broken nail is undetermined but suspected to be caused by fatigue from non-union.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 with this type of failure 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 activities.

Event Description

We became aware on (b)(4) 2018 that a sign im nail implanted to repair a fracture was replaced due to a non-union and broken nail.The broken im nail was replaced with a 10mm x 360mm standard nail per the sign technique manual.

• 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: 8171348
• MDR Text Key: 130610485
• Report Number: 3034525-2018-00149
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AF
• 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: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2015
• 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: 48 YR
• Patient Weight: 64