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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 Problem Positioning Problem (3009)
Patient Problem Bone Fracture(s) (1870)
Event Date 08/31/2018
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 difficulty in positioning is undetermined. 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 (b)(6) 2018 that a sign im nail implanted to repair a fracture was replaced due to poor positioning of the nail. The im nail was replaced with a 8mm x 280mm fin nail per the sign technique manual.
 
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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 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 Key7882048
MDR Text Key120451390
Report Number3034525-2018-00116
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCM
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 09/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2018
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 Received09/06/2018
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: 09/17/2018 Patient Sequence Number: 1
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