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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 Positioning Problem (3009)
Patient Problem Bone Fracture(s) (1870)
Event Date 05/13/2020
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 exchange is poor positioning. The radiographic and clinical data were reviewed by a sign orthopedic surgeon. This failure does not indicate a defect in the product. A minimal risk is associated with this failure. Sign fracture care international continues to monitor these events as part of our post market surveillance activities.
 
Event Description
We became aware on 6/04/2020 that a sign fin nail implanted to repair a fracture was replaced due to poor positioning. The fin nail was replaced with a 10mm x 340mm fin 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
Manufacturer (Section G)
SIGN FRACTURE CARE INTERNATIONAL
451 hills street
suite b
richland, wa
Manufacturer Contact
robert schmitt
451 hills street
suite b
richland, wa 
3711107
MDR Report Key10164759
MDR Text Key195479286
Report Number3034525-2020-00091
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeTO
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
Report Date 06/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2020
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 Received06/04/2020
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: 06/17/2020 Patient Sequence Number: 1
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