MAUDE Adverse Event Report: SYNTHES (USA) TITANIUM ELASTIC NAIL 440MM; PIN,FIXATION,SMOOTH

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

Patient Problems Non-union Bone Fracture (2369); Reaction (2414)

Event Date 05/07/2013

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article: ¿single-bone intramedullary fixation of unstable both-bone diaphyseal forearm fractures in children leads to increased re-displacement: a multicenter randomized controlled trial¿.Both-bone diaphyseal forearm fractures in children can be stabilised without cast by a flexible intramedullary nail in both the radius and the ulna.Adequate results with single-bone fixation combined with a complementary cast are also reported.The primary aim of the study was to investigate whether single-bone fixation, compared with both-bone fixation, causes equal limitation of pronation/supination at 9-month post-trauma.Between january 2006 and august 2010 a total of 24 children in four dutch hospitals, aged <16 years, with a displaced unstable both-bone diaphyseal forearm fracture were randomly allocated to single-bone or both-bone intramedullary fixation, of these, 11 were randomised to single-bone fixation and 13 to both-bone fixation.The group with single-bone fixation consisted of seven fractures with fixation of only the radius, and four with fixation of only the ulna.The group randomised to both-bone fixation consisted of 11 fractures with fixation of both the ulna and radius, and two with fixation of only the ulna.In case of allocation to single-bone fixation, the surgeon could stabilise the most unstable bone with an intramedullary nail.Titanium elastic nails (synthes) were used, with a diameter of 2.0¿ 3.0 mm depending on individual patient anatomy.Primary outcome was limitation of pronation and supination 9 months after initial trauma.Secondary outcomes were limitation of flexion/extension of wrist/elbow, complication rate, operation time, cosmetics of the fractured arm, complaints in daily life, and assessment of radiographs.A malunion, as defined by primary reduction criteria, was found in 3 children at final follow-up with 5 degree, 20 degree and 40 degree limitation of pronation/supination, respectively.One of these three children suffered from an open fracture and another one needed an open reduction and sustained a re-fracture.These three children were aged 10, 11 and 13 years, respectively.Re-displacement of the fracture occurred in four children (11 degree, 12 degree, 16 degree and 19 degree of angulation, respectively) during the first 6 weeks and only of fractures without an intramedullary nail.One child sustained a re-fracture after removal of the nails, while another child had a re-fracture of both the radius and ulna with bending of the nails inside the bones.Only the re-fractures were secondarily reduced.Furthermore, one superficial infection was seen and treated with oral antibiotics.One child who was treated with single-bone fixation of the ulna developed a non-union of the ulna and was successfully treated with removal of the nail, open reduction and internal fixation with a plate.One child experienced nail removal that was impossible.In the present study, re-displacement of the fracture occurred in 4 children and only in those treated with single-bone fixation.Not surprisingly, all re-displacements were seen in the bone without intramedullary fixation.Such re-displacement in single-bone intramedullary fixation of both-bone forearm fractures is common.These results caution against the use of single-bone fixation in all both-bone forearm fractures.This method may lead to increased re-displacement and reduced clinical results.Therefore, in children, we suggest that unstable both-bone diaphyseal forearm fractures should be stabilised with an intramedullary nail in both the radius and ulna to prevent re-displacement.This is 4 of 5 reports for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment not diagnosis.The gender of the patient with the re-fracturing of both the radius and ulna with bending of the nails inside the bones may have been male.Colaris, j., et al (2013 may 7).Single-bone intramedullary fixation of unstable both-bone diaphyseal forearm fractures in children leads to increased re-displacement: a multicenter randomized controlled trial.Arch orthop trauma surg.133:pp.1079-1087.This report is for 4 patients had re-displacement of fracture.One patient re-fractured both radius and ulna with bending of nails inside bones with secondary reduction.One patient developed non-union of ulna and successfully treated with removal of nail, open reduction and internal fixation with plate.Patients were implanted with one or more of the following devices based on anatomy, 2.0mm titanium elastic nail 440mm; 2.5mm titanium elastic nail 440mm; 3.0mm titanium elastic nail 440mm.Patients were implanted with one or more of the following devices based on anatomy, 475.920; 475.925; 475.930.Unknown.Patients surgically treated with implants between january 2006 and august 2010.Investigation could not be completed and no conclusion could be drawn, as no devices were returned and no lot numbers or part numbers were provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TITANIUM ELASTIC NAIL 440MM
• Type of Device: PIN,FIXATION,SMOOTH
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3774599
• MDR Text Key: 4377218
• Report Number: 2520274-2014-11070
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK971783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2014
• Initial Date FDA Received: 04/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention