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

Device Problem Failure to Osseointegrate (1863)

Patient Problem Inadequate Osseointegration (2646)

Event Date 08/16/2015

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.The radiographic and clinical data were reviewed by a sign orthopedic surgeon.The original im nail was replaced with a 10mm x 340mm, standard nail using two proximal screws and two distal screws.Sign fracture care international will continue to monitor these events as part of our post market activities.

Event Description

It was reported on (b)(6) 2015, that a sign im nail implanted to treat a fracture of the right tibia; was replaced due to a non-union.

• 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
• Manufacturer (Section G): SIGN FRACTURE CARE INTERNATIONAL; 451 hills street, suite b; richland WA 99354
• Manufacturer Contact: rob teeter ; 451 hills street, suite b; richland, WA 99354 ; 5093711107
• MDR Report Key: 5078087
• MDR Text Key: 25831653
• Report Number: 3034525-2015-00160
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: HA
• 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: 08/20/2015

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: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2015
• Initial Date FDA Received: 09/15/2015
• 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: 31 YR