MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; MISC ORTHO SURGICAL INSTR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Scar Tissue (2060); Pressure Sores (2326); Non-union Bone Fracture (2369); Impaired Healing (2378); Post Operative Wound Infection (2446)

Event Date 12/10/2008

Event Type  Injury  

Manufacturer Narrative

The 510k: this report is for an unknown elastic nail/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is unknown.Explant date is unknown.Complainant part is not expected to be returned for manufacturer.Without a lot number, the device history records review could not be completed.The manufacture date is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.The reported event required medical/surgical intervention to preclude permanent damage to a body structure.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 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 as follow: a (b)(6) old child, (b)(6) had exposed hardware requiring hardware revision.A (b)(6) child (b)(6) had wound infection treated with oral antibiotics.A (b)(6) child (b)(6) had hypergranulation tissue treated with silver nitrate.A (b)(6) child had wound infection treated with oral antibiotics.A (b)(6) child, hypergranulation tissue treated with silver nitrate.A (b)(6) child had nonunion.The fracture was kept non-weight-bearing and was placed in a knee immobilizer.A (b)(6) child with had heel ulcer.This was treated with wound care and by unloading the heel.A (b)(6) old child (b)(6) had wound infection treated oral antibiotics.A (b)(6) child (b)(6) had nonunion.The fracture was kept non-weight-bearing and was placed in a knee immobilizer.A (b)(6) child with (b)(6) had ulcer from fracture brace.This was healed after modifications were made to the brace.A (b)(6) child (b)(6) had re-fracture requiring open reduction internal fixation (orif).A (b)(6) child (b)(6) had postoperative peroneal nerve palsy.A (b)(6) child (b)(6) had nonunion.The fracture was kept non-weight-bearing and was placed in a knee immobilizer.A (b)(6) child with (b)(6) had prominent hardware.A (b)(6) child had prominent hardware.A (b)(6) child had proximal nail exiting lesser trochanter.This report is for an unknown synthes flexible titanium intramedullary nail.(b)(4).

• Type of Device: MISC ORTHO SURGICAL INSTR
• 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: 7715060
• MDR Text Key: 114879941
• Report Number: 2939274-2018-53054
• Device Sequence Number: 1
• Product Code: LXH
• 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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• 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