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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 03/16/2022
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. A second surgery was performed to remove the nail. Removal does not indicate a defect in the product or a failure of the implant. A minimal risk is associated with this failure. Sign fracture care international continues to monitor these events as part of our post market activities.
 
Event Description
We became aware on 3/28/2022, that a sign im nail implanted to repair a fracture had to be removed due to non-union and infection.
 
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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 Key14017497
MDR Text Key288776179
Report Number3034525-2022-00048
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeMI
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 03/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2022
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 Received03/28/2022
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: 04/05/2022 Patient Sequence Number: 1
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