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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Discomfort (2330)
Event Date 01/20/2007
Event Type  Injury  
Manufacturer Narrative
Patient information is not available for reporting. Date of event: there are multiple unknown dates of event. This report is for an unknown screw/unknown lot. Part and lot numbers are unknown; udi number is unknown. Implanted date: there are multiple unknown dates of implantation between (b)(6) 1999 and (b)(6) 2004. Explanted date: it is unknown if or when devices were explanted. Complainant part is not expected to be returned for manufacturer review/investigation. 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. 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. (b)(4).
 
Event Description
This report is being filed after the review of the following journal article: morshed s, et al (2007). Retention of flexible intramedullary nails following treatment of pediatric femur fractures. Archives of orthopaedic and trauma surgery. Volume 127. Issue 7. Pages 509-514. (usa). The purpose of this study is to describe the natural history of treatment of pediatric femur fractures with retention of flexible intramedullary nails as measured by need for further surgery and residual symptoms. Between october 1999 and march 2004, 24 school age children (25 femurs) who underwent internal fixation of a diaphyseal femur fracture with flexible titanium nails without planned implant removal, were included in the study. There were 4 girls and 20 boys with a mean age of 9. 2 years (range, 6. 5-13 years). Patients were implanted with 2 to 3 unknown synthes titanium elastic nail in a retrograde fashion through the distal part of the femur depending on fracture pattern and stability. Follow-up with radiographic examination and assessment of alignment, callus formation, and the status of the implants were done until fractures had healed and patients had returned to full activity. Patients and caregivers were assessed using questionnaires regarding the presence or absence of pain (scale from 1 to 10), incidence of further complications or requirement of a second surgery to remove the nails average follow-up was 3. 6 years (range 1. 4¿4. 8 years). Complications were reported as follows: four patients with rods in place reported thigh discomfort. A 10. 3 year old male child, with right side transverse middle third femoral fracture, had implant removal at 1. 6 years post-op due to pain and irritation. Local irritation improved following nail removal. A 10. 3 year old male child, with left side transverse distal third femoral fracture, had implant removal at 1. 6 years post-op due to pain and irritation. Local irritation improved following nail removal. A 6. 6 year old male child, with right side oblique middle third femoral fracture, had implant removal at 0. 6 years post-op due to pain and irritation. Local irritation improved following nail removal. A 9. 1 year old female child, with left side oblique middle third femoral fracture, had implant removal at 0. 7 years post-op due to pain and irritation. Local irritation improved following nail removal. A 13 year old male child, with right side spiral proximal third femoral fracture, had implant removal at 2. 8 years post-op due to pain and irritation. Local irritation improved following nail removal. A 10. 4 year old male child, with right side oblique middle third femoral fracture, had implant removal at 1 year post-op due to pain and irritation. Local irritation improved following nail removal. This report is for one (1) device- an unknown synthes titanium elastic nail. This is report 2 of 7 for (b)(4).
 
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Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7902044
MDR Text Key121563863
Report Number2939274-2018-53910
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/24/2018 Patient Sequence Number: 1
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