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U.S. Department of Health and Human Services

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

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SIGN FRACTURE CARE INTERNATIONAL SIGN IM NAIL INTRAMEDULLARY FIXATION ROD Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Post Operative Wound Infection (2446); Limb Fracture (4518)
Event Date 03/29/2022
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 infection is undetermined. Infections have many causes and treatments. Each infection is addressed individually and taken very seriously by both the attending surgeon and sign surgeons at sign headquarters. The radiographic and clinical data were reviewed by a sign orthopedic surgeon. This failure does not indicate a defect in the product. The risk associated was evaluated during the risk management process and was deemed an acceptable level of risk to the patient. Sign fracture care international continues to monitor these events as part of our post market surveillance 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 infection. The im nail was replaced with a 10mm x 280mm standard im nail per the sign technique manual. Surgeon comment: "this fracture failed to heal and nail was removed in december last year due to infection. The patient was placed on ex-fix from that time and this time we exposed the fracture site, debrided and reamed the canal, saline irrigation up and down. Fractured fibula and cut the fracture edge with a saw, shortened the limb and placed sign nail. ".
 
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Brand NameSIGN IM NAIL
Type of DeviceINTRAMEDULLARY 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 Key14142775
MDR Text Key289518503
Report Number3034525-2022-00054
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeBY
PMA/PMN Number
K022632
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2022
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 Received04/07/2022
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 Treatment Data
Date Received: 04/19/2022 Patient Sequence Number: 1
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