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U.S. Department of Health and Human Services

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

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SIGN FRACTURE CARE INTERNATIONAL SIGN FIN NAIL INTRAMEDULLARY FIXATION ROD Back to Search Results
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Patient Problem Bone Fracture(s) (1870)
Event Date 02/21/2018
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 non-union and loosening 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. (b)(4) continues to monitor these events as part of our post market surveilance activities.
 
Event Description
We became aware on 12/22/2016 that a sign im nail implanted to repair a fracture was replaced due to a non-union and nail loosening. The im nail was replaced with a 10mm x 340mm fin nail per the sign technique manual. Surgeon comment: "(b)(6) has been having pain because the nail was protruding into the knee. We missed the slots in his first surgery. Today we removed the standard interlocking nail and replaced it with a fin nail because there was still motion at the fracture site. ".
 
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Brand NameSIGN FIN NAIL
Type of DeviceINTRAMEDULLARY FIXATION ROD
Manufacturer (Section D)
SIGN FRACTURE CARE INTERNATIONAL
451 hills street
suite b
richland, wa WA 99354 5502
Manufacturer (Section G)
SIGN FRACTURE CARE INTERNATIONAL
451 hills street
suite b
richland, wa WA 99354 5502
Manufacturer Contact
robert schmitt
451 hills street
suite b
richland, wa, WA 99354-5502
5093711107
MDR Report Key6216448
MDR Text Key63686771
Report Number3034525-2016-00322
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeNI
PMA/PMN Number
K043200
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received02/27/2018
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: 12/30/2016 Patient Sequence Number: 1
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