MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PIN, FIXATION, SMOOTH

Device Problem Migration (4003)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient height reported as 152cm.Patient age reported as (b)(6).Date of event is unknown.This report is for an unknown flexible titanium intramedullary nail.Part and lot numbers are unknown; udi number is unknown.Date of implantation is unknown date between 1998 and 2003.It is unknown if or when device was explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter phone number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made, the investigation will be updated as applicable.(b)(4).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: weiss, jm.Et al (2009), complications with flexible nailing of femur fractures more than double with child obesity and weight >50 kg, journal of child orthopedic, vol.3, pages 53-58 (united states of america).The purpose of this retrospective study is to examine whether obesity, defined as bmi > 95th percentile, and/or weight correlates with an increased rate of complications after titanium elastic nailing for femur fractures in children.Between 1998 and 2003, 71 patients (51 male and 20 female) with the average age of 9 years and 3 months (range, 4-15 years) who had diaphyseal femur fractures were treated with an unknown synthes flexible titanium intramedullary nail.Children who placed over the 95th percentile were considered ¿obese.¿ those between the 85th and 95th percentiles were considered ¿at risk of obesity, ¿5th to 85th as ¿healthy weight,¿ and those below the 5th percentile were considered ¿underweight.¿ the following complications were reported: a (b)(6) child with 106 cm in height, (b)(6) in weight, bmi of 16 and 68th percentile had exposed hardware requiring hardware revision.A (b)(6) child with 123 cm in height, (b)(6) in weight, bmi of 17 and 84th percentile had wound infection treated with oral antibiotics.A (b)(6) child with 127 cm in height, (b)(6) in weight, bmi of 18 and 89th percentile had hypergranulation tissue treated with silver nitrate.An (b)(6) child with 158 cm in height, (b)(6) in weight, bmi of 12 and <1st percentile had wound infection treated with oral antibiotics.A (b)(6) child with 138 cm in height, (b)(6) in weight, bmi of 17 and 64th percentile hypergranulation tissue treated with silver nitrate.A (b)(6) child with 155 cm in height, (b)(6) in weight, bmi of 15 and 1st percentile had nonunion.The fracture was kept non-weight-bearing and was placed in a knee immobilizer.A (b)(6) child with 135 cm in height, (b)(6) in weight, bmi of 20 and 97th percentile had heel ulcer.This was treated with wound care and by unloading the heel.A (b)(6) child with 149 cm in height, (b)(6) in weight, bmi of 19 and 82nd percentile had wound infection treated oral antibiotics.A (b)(6) child with 160 cm in height, (b)(6) in weight, bmi of 20 and 44th percentile had nonunion.The fracture was kept non-weight-bearing and was placed in a knee immobilizer.A (b)(6) child with 134 cm in height, (b)(6) in weight, bmi of 28 and 98th percentile had ulcer from fracture brace.This was healed after modifications were made to the brace.A (b)(6) child with 134 cm in height, (b)(6) in weight, bmi of 29 and 99th percentile had re-fracture requiring open reduction internal fixation (orif).An (b)(6) child with 135 cm in height, (b)(6) in weight, bmi of 30 and 99th percentile had postoperative peroneal nerve palsy.A (b)(6) child with 157 cm in height, (b)(6) in weight, bmi of 35 and 99th percentile had nonunion.The fracture was kept non-weight-bearing and was placed in a knee immobilizer.A (b)(6) child with 181 cm in height, (b)(6) in weight, bmi of 28 and 97th percentile had prominent hardware.An (b)(6) child with 123 cm in height, (b)(6) in weight, bmi of 17 and 71st percentile had prominent hardware.An (b)(6) child with 152 cm in height, (b)(6) in weight, bmi of 16 and 13th percentile had proximal nail exiting lesser trochanter.This report is for an unknown synthes flexible titanium intramedullary nail.This report captures an (b)(6) child who had a proximal nail exiting the lesser trochanter.This is report 6 of 6 for (b)(4).

• Type of Device: PIN, FIXATION, SMOOTH
• 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: 7715007
• MDR Text Key: 114934508
• Report Number: 2939274-2018-53050
• Device Sequence Number: 1
• Product Code: HTY
• 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: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2018
• 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
• Patient Weight: 36