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

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

Patient Problem Reaction (2414)

Event Date 05/22/2012

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article: intramedullary nails for pediatric diaphyseal femur fractures in older, heavier children: early results; reynolds, r.A.A., legakis, j.E., thomas, r., slongo, t.F., hunter, j.B., clavert, j.(may 22, 2012).Intramedullary nails for pediatric diaphyseal femur fractures in older, heavier children: early results.J child orthop 6:181-188.This was a retrospective cohort study reviewing medical records of 22 children ages 10-17 requiring surgical fixation of a femur fracture for a period of 2.5 years.Seven (7) patients were treated with elastic stable intramedullary nails (esins) without end-caps and 15 patients were treated with adolescent lateral entry femoral nails (alfns, synthes).Of the patients in the alfn group (demographics: age range 10-16 years, 11 percent male, mean weight 59.6 kg), 46.7 percent experienced minor complications such as pain, implant pain, or irritation.This report is 1 of 1 for complaint (b)(4).This report is for an unknown adolescent lateral entry femoral nail.

Manufacturer Narrative

Reynolds, r.A.A., legakis, j.E., thomas, r., slongo, t.F., hunter, j.B., clavert, j.(may 22, 2012).Intramedullary nails for pediatric diaphyseal femur fractures in older, heavier children: early results.J child orthop 6:181-188.Report is for an unknown adolescent lateral entry femoral 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: 3768556
• MDR Text Key: 4375548
• Report Number: 2520274-2014-11018
• 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: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2014
• Initial Date FDA Received: 04/23/2014
• 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
• Patient Outcome(s): Required Intervention