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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIGN FRACTURE CARE INTERNATIONAL STANDARD IM NAIL; INTRAMEDULLARY ROD
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SIGN FRACTURE CARE INTERNATIONAL STANDARD IM NAIL; INTRAMEDULLARY ROD Back to Search Results
Model Number STANDARD IM NAIL
Device Problem Failure to Osseointegrate (1863)
Patient Problem Non-union Bone Fracture (2369)
Event Date 03/27/2014
Event Type  Injury  
Event Description
Cause: non-union of fracture site.Fracture repair and healing is always unique to the pt and the fracture.Guidance on best practice for sign nailing surgery is included in the sign technique manual; however no one can predict a non-union or a failure.Therefore no corrective action is indicated or would help prevent this type of situation from happening again.No indication of product defect.
 
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Brand Name
STANDARD IM NAIL
Type of Device
INTRAMEDULLARY ROD
Manufacturer (Section D)
SIGN FRACTURE CARE INTERNATIONAL
richland WA 99354
Manufacturer Contact
doug donnelly
451 hills st
ste b
richland, WA 99354
5093761107
MDR Report Key3736090
MDR Text Key17155653
Report Number3034525-2014-00017
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K022632
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Physician
Remedial Action Replace
Type of Report Initial
Report Date 04/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSTANDARD IM NAIL
Device Catalogue NumberSTANDARD IM NAIL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/02/2014
Initial Date FDA Received04/04/2014
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 Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age48 YR
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