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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP IM FEMORAL NAIL, 9 MM X 34CM, RIGHT

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ORTHOPEDIATRICS, CORP IM FEMORAL NAIL, 9 MM X 34CM, RIGHT Back to Search Results
Model Number 10-1500-044
Device Problem Fracture (1260)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  malfunction  
Event Description
Dr. (b)(6) was removing the pedinail by patient request. He properly attached the extraction bolt, removed all of the screws and attached the backslap to the extraction bolt. He backslapped a few times and the nail broke at the distal most screw hole leaving more than 2/3 of the nail in the canal of the patients femur.
 
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Brand NameIM FEMORAL NAIL, 9 MM X 34CM, RIGHT
Type of DeviceIM FEMORAL NAIL
Manufacturer (Section D)
ORTHOPEDIATRICS, CORP
2850 frontier drive
warsaw IN 46582
MDR Report Key12639992
MDR Text Key281659037
Report Number3006460162-2021-00042
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10-1500-044
Device Catalogue Number10-1500-044
Device Lot Number105448-1
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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