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 06/17/2015

Event Type  Injury  

Event Description

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

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.There is no way to predict a non-union or failure to heal.The first im nail was replaced with a 10mm x 340mm, standard nail using two proximal screws and one distal screw.Sign fracture care international will continue to monitor these events as part of our post market activities.

• 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: 4892214
• MDR Text Key: 6071084
• Report Number: 3034525-2015-00110
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: TZ
• PMA/PMN Number: K022632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2015

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: 06/25/2015
• Initial Date FDA Received: 07/06/2015
• 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: 32 YR