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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/09/2016

Event Type  malfunction  

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 failure to heal is patient failure to use crutches.The radiographic and clinical data were reviewed by a sign orthopedic surgeon.A second surgery was performed to remove the nail.Sign fracture care international continues to monitor these events as part of our post market activities.

Event Description

We became aware on 3/31/2016, that a sign nail implanted on (b)(6) 2015 to repair a fracture had to be removed due to patient failure to heal.Nail was replaced with a non-sign product; blade plate.Surgeon comments: (b)(6) 2015 "the patient had failed to use crutches and proximal fixation has been lost, fracture has impacted about 2cm.Continue touch weight bearing for now and see if he unites." (b)(6) 2016 "a disaster! he's booked for revision surgery, either revision nailing or a blade plate." (b)(6) 2016 "complete failure of implant with non union and shortening.Nail removed and revised to 90deg blade plate with iliac bone grafting.".

• Brand Name: SIGN IM NAIL
• Type of Device: INTRAMEDULLARY FIXATION ROD
• Manufacturer (Section D): SIGN FRACTURE CARE INTERNATIONAL; 451 hills street, suite b; 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: 5575458
• MDR Text Key: 42611646
• Report Number: 3034525-2016-00086
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: MI
• 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: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2016
• Initial Date FDA Received: 04/13/2016
• 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 Age: 54 YR
• Patient Weight: 91