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

Device Problem Migration (4003)

Patient Problem Limb Fracture (4518)

Event Date 01/18/2022

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. There is no way to predict a non-union or failure to heal. The root cause of the migration is inadequate distal locking. The radiographic and clinical data were reviewed by a sign orthopedic surgeon. This failure does not indicate a defect in the product. A minimal risk is associated with this failure. Sign fracture care international continues to monitor these events as part of our post market surveilance activities.

Event Description

We became aware on (b)(6) 2022 that a sign im nail implanted to repair a fracture was replaced due to a non-union with migration. The im nail was replaced with a 10mm x 340mm standard im nail per the sign technique manual. Sugrgeon comment: "distal migration of nail , because of inadequate distal locking , exchange sign nail done".

• 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: 13895755
• Report Number: 3034525-2022-00044
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: PK
• 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

• Type of Report: Initial
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2022
• 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 Age: 55 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Outcome(s): Hospitalization; Required Intervention