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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 11/27/2016
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 and broken nail is undetermined. The radiographic and clinical data were reviewed by a sign orthopedic surgeon. There is no way to predict a non-union or failure to heal. Sign fracture care international continues to monitor these events as part of our post market activities.
 
Event Description
We became aware on (b)(6) 2016 that a sign im nail implanted to repair a fracture was exchanged due to a non-union and a broken nail. The broken im nail was replaced with a 10mm x 320mm 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 Key6146162
MDR Text Key61491234
Report Number3034525-2016-00310
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeBG
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 12/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2016
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 Received12/01/2016
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: 12/05/2016 Patient Sequence Number: 1
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