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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 Break (1069)
Patient Problem Bone Fracture(s) (1870)
Event Date 11/15/2018
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 broken nail is undetermined but suspected to be caused by fatigue from non-union. 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 with this type of failure 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 activities.
 
Event Description
We became aware on (b)(4) 2018 that a sign im nail implanted to repair a fracture was replaced due to a non-union and broken nail. The broken im nail was replaced with a 10mm x 360mm standard nail per the sign technique manual.
 
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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 Key8171348
MDR Text Key130610485
Report Number3034525-2018-00149
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAF
PMA/PMN Number
K022632
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 11/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2015
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: 12/17/2018 Patient Sequence Number: 1
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