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

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

There are multiple unknown dates of event.510k: this report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.There are multiple unknown dates of implantation between october 1999 and march 2004.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: 4 patients with rods in place reported thigh discomfort.A (b)(6) 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 (b)(6) 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 (b)(6) 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 (b)(6) 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 (b)(6) 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 (b)(6) 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 7 of 7 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• Type of Device: ROD, 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 Key: 7902052
• MDR Text Key: 121563166
• Report Number: 2939274-2018-53915
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 09/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention