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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 11/06/2021
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. 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 surveilance activities.
 
Event Description
We became aware on (b)(6) 2021, that a sign im nail implanted to repair a fracture had to be removed due to non-union with 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 Key13121366
MDR Text Key283156951
Report Number3034525-2021-00194
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodePK
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 12/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2021
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 Received12/28/2021
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: 12/30/2021 Patient Sequence Number: 1
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