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

Device Problem Failure to Osseointegrate (1863)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

This report is being filed after subsequent review of the following journal article.Ozdemir, b., akesen, b., demirag, b., bilgen, m.S., and durak, k., (2012, march).Long-term outcome of unreamed intramedullary nails in femur diaphyseal fractures.Turkish journal of trauma and emergency surgery, 18 (2), 147-152.The authors conducted a study of 25 adults (19 male, six female, average age 31 years) with 29 traumatic femur diaphyseal fractures who had undergone unreamed intramedullary nailing with a synthes unreamed femoral nail between january 1997 and december 2007.On follow-up (mean follow-up time was 65 months), there was non-union in one (b)(6) male which was treated by reamed intramedullary nail and autograft from the iliac crest.Two patients experienced malunion.This is report 1 of 2 for complaint (b)(4).This report is for an unknown femoral nail.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Ozdemir, b., akesen, b., demirag, b., bilgen, m.S., and durak, k., (2012, march).Long-term outcome of unreamed intramedullary nails in femur diaphyseal fractures.Turkish journal of trauma and emergency surgery, 18 (2), 147-152.This report is for an unknown 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: 3761850
• MDR Text Key: 17839940
• Report Number: 2520274-2014-10852
• 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: 04/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• 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
• Date Manufacturer Received: 04/04/2014
• 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
• Patient Age: 32 YR