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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 7MM X 280MM CHILD NAIL, RIGHT

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ORTHOPEDIATRICS, CORP 7MM X 280MM CHILD NAIL, RIGHT Back to Search Results
Model Number 00-1502-0728
Device Problem Fracture (1260)
Patient Problem Insufficient Information (4580)
Event Date 01/28/2022
Event Type  malfunction  
Event Description
Sent the nail down with no issue. Had reamed to a 9 for a 7 nail. Broke the femur. Then continued to send the nail down. Took an x-ray once completely implanted and discovered the distal bend through the most proximal screw hole. We then tried to take the nail out but it could not make it back up the canal with the bend. Re-buried it and it is still in the patient.
 
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Brand Name7MM X 280MM CHILD NAIL, RIGHT
Type of DeviceCHILD NAIL
Manufacturer (Section D)
ORTHOPEDIATRICS, CORP
2850 frontier drive
warsaw IN 46582
Manufacturer (Section G)
ORTHOPEDIATRICS, CORP
2850 frontier drive
warsaw IN 46582
Manufacturer Contact
james gunnels
2850 frontier drive
warsaw, IN 46582
MDR Report Key13714925
MDR Text Key289492342
Report Number3006460162-2022-00004
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number00-1502-0728
Device Catalogue Number00-1502-0728
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No

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