MAUDE Adverse Event Report: SYNTHES USA; NAIL, FIXATION, BONE

Device Problems Bent (1059); Break (1069)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment not diagnosis.Additional narrative: this report is for an unknown 8mm and 9mm size small diameter tibial nails, unknown quantity.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article received: this report is being filed after the subsequent review of the following literature article.Hutson,j.J., md et al (june 1995) "mechanical failures of intramedullary tibial nails applied without reaming", clinical orthopaedics and related research, number 315,pp.129-137.The purpose of this study was to gather information to define the modes of mechanical failure after undreamed tibial nailing.Then in, vitro testing could be developed to study the clinical behavior, and ultimately be used as a tool to evaluate design and material changes that might be appropriate for clinical application.During a nonrandomized retrospective multicenter study, 322 tibial fractures in 295 patients were treated with either another manufacturer or synthes ((b)(4)) 8mm and 9mm sizes of small diameter tibial nail without reaming and followed union.Mechanical failure of the nail or locking screws developed in 46 patients (14%).Of the 80 fractures from the university of (b)(6) treated with the synthes nail, there were 40 diaphyseal fractures with 4 cases of mechanical failures.One patient with secondary trauma bent the nail at the fracture site.There were 3 screw failures associated with diaphyseal fractures that resulted in 2 broken and 4 bent screws between 10 and 18 weeks after nailing (mean, 14 weeks).There were 12 proximal fractures with 4 mechanical failures.In this group, there were 3 screw and 1 nail failures through a proximal screw hole.The screw failures included 4 bent and 3 broken screws, with the average time to failure of 13 weeks (range, 4-23 weeks).Of the 28 distal fractures, there were 4 cases with screw failure that resulted in 5 broken and 2 bent screws.One nail broke through the most proximal of the 2 distal screw holes.The average time to failure was 15 weeks (range, 11-19 weeks).Of the 10 mechanical failures, only 2 required revision (clinical failures), 1 proximal and 1 distal fracture, each with a broken nail.Of the 40 cases from the university of (b)(6) treated with a synthes nail, there were 24 diaphyseal fractures: two patients had 3 screw failures at 10 and 12 weeks after fracture, and there were no nail failures.Of the 2 proximal fractures, there were no mechanical failures.Of the 14 distal fractures, there were 6 patients with 12 screw failures between 6 and 18 weeks after fracture (mean, 11.2 weeks), and no broken nails.Only 1 of the 8 cases of mechanical failure required revision.Of the 199 synthes nails, there were 41 distal fractures with 11 mechanical failures (27%); 10 screw and 1 nail failure (2.4%).For the synthes nail under the same set conditions in vitro, the failure mode included bending of the distal tip of the nail and bent or fractured distal screws that also were consistent with the clinical observations using this implant.This is report 1 of 2 for (b)(4) for unknown 8mm and 9mm sizes of small diameter tibial nails.For the following events: of the 80 fractures from the university of (b)(6) treated with the synthes nail, there were 40 diaphyseal fractures with 4 cases of mechanical failures.One patient with secondary trauma bent the nail at the fracture site.There were 12 proximal fractures with 4 mechanical failures.In this group, there was 1 nail failure through a proximal screw hole.Of the 28 distal fractures, one nail broke through the most proximal of the 2 distal screw holes.Of the 10 mechanical failures, only 2 required revision (clinical failures), 1 proximal and 1 distal fracture, each with a broken nail.Of the 199 synthes nails, there were 41 distal fractures with 11 mechanical failures; 1 nail failure.

• Type of Device: NAIL, FIXATION, BONE
• 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: 5426808
• MDR Text Key: 37850751
• Report Number: 2520274-2016-10923
• Device Sequence Number: 1
• Product Code: JDS
• 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,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2016
• 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