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 11/14/2016

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 broken nail 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.The broken im nail was replaced with a 10mm x 360mm, standard nail per the sign technique manual.Sign fracture care international continues to monitor these events as part of our post market activities.

Event Description

We became aware on 12/16/2016 that a sign im nail implanted to repair a fracture was exchanged due to a non-union and a broken nail.The broken im nail was replaced with a 10mm x 340mm 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: 6191952
• MDR Text Key: 62907218
• Report Number: 3034525-2016-00319
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CM
• 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: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2016
• 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: 46 YR
• Patient Weight: 64