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

Device Problem Failure to Osseointegrate (1863)

Patient Problem Ambulation Difficulties (2544)

Event Type  malfunction  

Event Description

This report is being filed after the subsequent review of the following journal article: duan, x., al-qwbani, m., zeng, y., zhang, w., and xiang, z.(2012).Intramedullary nailing for tibial shaft fractures in adults (review).Reprint by wiley of the cochrane review, prepared and maintained by the cochrane collaboration and published in the cochrane library 2012, issue 1, 1-57.The authors conducted a study to assess the effects of different methods and types of intramedullary nailing for treating tibial shaft fractures in adults.They included the following comparisons: reamed versus unreamed nailing; locked versus unlocked nailing; and titanium versus stainless steel nails.A search was conducted on the cochrane bone, joint and muscle trauma group specialized register, the cochrane central register of controlled trials, medline, embase and reference lists of articles to december 2009.The search was subsequently updated to september 2011 to include more recent literature.Randomized and quasi-randomized controlled clinical studies evaluating different methods and types of intramedullary nailing for treating tibial shaft fractures in adults were included.Primary outcomes were health-related quality of life, patient-reported function and re-operation for treatment failure or complications.Nine randomized and two quasi-randomized clinical trials, involving a total of 2093 participants with 2123 fractures, were included.Overall, 1535 participants were men, 542 were women and gender was not specified with 18.At least two review authors independently performed study selection, risk of bias assessment, and data collection and extraction.Six trials compared intramedullary nail fixation following reaming of intramedullary canal (reamed group) versus intramedullary nail fixation without prior reaming (unreamed group).Court-brown (1996) compared the reamed tibial nail of a competitor versus synthes device, ao unreamed tibial nail.Larsen (2004) compared the reamed stainless steel nail of a competitor versus synthes device, a solid, titanium unreamed nail (ao tibial nail).The results for the court-brown article with synthes unreamed tibial nail included major operation (bone graft, implant exchange, infection): six of 25; implant exchange or bone graft for nonunion: five of 25; pain: 14 of 25; malunion, limp: four of 25; implant failure (screw or nail): 14 of 25; compartment syndrome: three of 25.The results for the larsen article with synthes device, a solid, titanium unreamed tibial nail included major operation (bone graft, implant exchange, infection): one of 23; implant exchange or bone graft for nonunion: one of 23; nonunion: three of 23; pain: nine of 23; malunion, limp: four of 23; implant failure (screw or nail): three of 23; compartment syndrome: four of 23.The authors found no statistically significant differences between the reamed and unreamed nailing groups in major reoperations or in the secondary outcomes of nonunion, pain, malunion, nonunion and compartment syndrome.They concluded that there was insufficient evidence to draw definitive conclusions on the best type of, or technique for, intramedullary nailing for tibial shaft fractures in adults.This is a reportable malfunction report for synthes unreamed tibial nail referenced in court-brown publication: malunion, limp: four of 25; implant failure (screw or nail): 14 of 25.This report is for an unreamed tibial nail.This is report 2 of 4 for complaint (b)(4).

Manufacturer Narrative

This device was used for treatment, not diagnosis.Duan, x., al-qwbani, m., zeng, y., zhang, w., and xiang, z.(2012).Intramedullary nailing for tibial shaft fractures in adults (review).Reprint by wiley of the cochrane review, prepared and maintained by the cochrane collaboration and published in the cochrane library 2012, issue 1, 1-57.This report is for an unknown unreamed tibial nail.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 3776515
• MDR Text Key: 18544514
• Report Number: 2520274-2014-11079
• 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: Other,Foreign,Literature,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2014
• Is this an Adverse Event Report?: No
• 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: 04/08/2014
• 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