MAUDE Adverse Event Report: SYNTHES SYNTHES TNS NAIL; FEMORAL NAIL

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); Injury (2348); Ambulation Difficulties (2544)

Event Date 07/09/2011

Event Type  Injury  

Event Description

On (b)(6) 2011 i was injured in a fall.My femur was broken and dr.(b)(6), a local hand surgeon did surgery and implanted a synthes tns nail into my femur and hip.Within a few months i went to the dr.And told him something was wrong and that i wanted the device removed.I tried several times, with several doctors, to get it taken out.I was told if they try to remove it and the leg rebreaks it will have to be put back.I would then be worse off.Or so i thought.In the last five years the leg has gotten so bad that it is crippling me! i can feel the rod in my hip move and it has been digging into the piriformis and it feels like raw meat.I can also feel the screw from the rod in my femur digging into my thigh muscle.These muscles are now in agonizing, level 10 pain, 24/7 i can barely walk anymore and the pain is unbearable! it is pressing on my sciatic nerve and is now affecting both legs, though the left is worse.I can not bend over to even pick something off of the floor without screaming in pain.I cannot lift my feet/legs up to put myself in the bed without screaming! i cry every single day and night.It is robbing me of sleep and quality of life.I am afraid to go down four steps to get off my porch for fear of unimaginable pain and that i may not be able to get back up the steps.I think of suicide every single day! please help me! tell me what to do.I have rheumatoid arthritis and my body is already being destroyed.Because i cannot walk even in a semi-normal gait the rest of my body is being affected by this device.When i contacted the fda complaint department i was told there were only 3 other complaints.Please let me know if there is any kind of solution to this problem.I cannot continue to live like this!.

• Brand Name: SYNTHES TNS NAIL
• Type of Device: FEMORAL NAIL
• Manufacturer (Section D): SYNTHES
• MDR Report Key: 5795480
• MDR Text Key: 49623231
• Report Number: MW5063417
• Device Sequence Number: 1
• Product Code: JDS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 58 YR
• Patient Weight: 59