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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP IM FEMORAL NAIL, 9 MM X 32CM, RIGHT

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ORTHOPEDIATRICS, CORP IM FEMORAL NAIL, 9 MM X 32CM, RIGHT Back to Search Results
Model Number 10-1500-043
Device Problem Fracture (1260)
Patient Problem Insufficient Information (4580)
Event Date 01/04/2022
Event Type  malfunction  
Event Description
This nail was implanted in early 2017. Upon removal of screws, dr. (b)(6) threaded in the bullet tip extraction bolt and began to back slap the nail out of the femur. At this point, it was discovered that the proximal portion of the nail was broken apart from the distal portion of the nail at the transverse hole. Dr. (b)(6) then decided to leave the left femoral nail in the patient and also left the rest of the right side in (that had broken off). Delay greater than 30 mins.
 
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Brand NameIM FEMORAL NAIL, 9 MM X 32CM, RIGHT
Type of DeviceIM FEMORAL 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 Key13714872
MDR Text Key289491316
Report Number3006460162-2022-00001
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 Number10-1500-043
Device Catalogue Number10-1500-043
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No

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