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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES ELMIRA 11.0MM TI HELICAL BLADE 90MM-STERILE ROD, FIXATION, INTRAMEDULLARY

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SYNTHES ELMIRA 11.0MM TI HELICAL BLADE 90MM-STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 456.303S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Numbness (2415); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Updated information. Bilateral knee replacement surgery on a date unknown. Device used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Update 8/2/2017: the patient reported new information of having had bilateral knee replacement surgery (date unknown) and that her knees were not healing properly as a result of her pain issue from synthes nail implant.
 
Manufacturer Narrative
This device was used for treatment, not diagnosis. Maude-medwatch report# 5063417 reported on 7/12/2016. Date of event: unknown. This report is for one (1) unknown rod. Udi#: unknown part number, udi is unavailable. (b)(4). Pma#; 510: this report is for one (1) unknown rod. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Maude-medwatch report# 5063417: it was reported that the patient had a fall on an unknown date in 2011 which resulted in a broken femur injury. On (b)(6) 2011 the surgeon implanted a synthes tns nail into the patient's femur and hip. Within a few months the patient went to doctor and told him something was wrong with the device and that she wanted it removed. The patient tried contacting several doctors, to get them to remove the implant, she was told if they remove the implant and if her leg re-breaks the implant will have to be put back in and that she would be worse off, or so she thought. In the last five years the leg has gotten so bad that it is crippling her. She can feel the rod in her hip when she moves and it digs into the piriformis and it feels like raw meat. The patient can also feel the screw from the rod in her femur digging into her muscle. The muscles are agonizing, with a level 10 for pain and for 24/7. The patient can barely walk anymore and the pain is unbearable. It is pressing on the patient's sciatic nerve and is now affecting both legs, her left leg is worse. The patient cannot bend over to even pick something up off the floor without screaming pain. She is afraid to go down four steps to get off her porch for fear of an unimaginable pain and that she may not be able to get back up the steps. She cannot lift her feet/legs up to put herself in bed without screaming. The patient states that she cries every single day and night and that she feels as though she is being robbed of her sleep and quality of life. The patients states that she thinks of suicide every single day. This report is for one (1) unknown rod. This report is 2 of 3 for (b)(4).
 
Manufacturer Narrative
Device has not been explanted. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Additional product codes for this report include hwc. (b)(4). Device history record review: manufacturing date: march 30, 2011 - expiration date: february 1, 2020. A review of the device history record revealed no complaint related anomalies. The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework nor non-conformities noted. This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition. A review of the raw material device history record revealed this lot met all specifications with no rework or non-conformances noted. This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition. (b)(4). Device used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name11.0MM TI HELICAL BLADE 90MM-STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES ELMIRA
35 airport road
horseheads NY 14845
Manufacturer (Section G)
SYNTHES ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5871951
MDR Text Key115808975
Report Number2520274-2016-14061
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K011857
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup,Followup
Report Date 07/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/01/2020
Device Catalogue Number456.303S
Device Lot Number6619609
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/30/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/12/2016 Patient Sequence Number: 1
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