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

Device Problem Failure to Osseointegrate (1863)

Patient Problems Unspecified Infection (1930); Impaired Healing (2378)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal abstract, hungria, j., and mercadante, m.(2013).Open tibial shaft fractures.Treatment with intramedullary nailing after provisional stabilization with non penetrating external fixator, rev bras ortop, 48, 482-490.The authors conducted a prospective study of 39 open tibial shaft fractures treated with synthes devices, non penetrating external fixator, pinless, followed by synthes unreamed intramedullary locked nail to evaluate the incidence of union, nonunion, deep infection and factors that influence the time of bone healing.Deep infection was reported in 2.6 percent of patients; malunion was seen in 5.1 percent; and bone healing was achieved in 97.4 percent of the cases.The authors concluded that the treatment of open tibial shaft fractures with unreamed intramedullary nailing allowed for low rates of deep infection and nonunion and high rates of bone healing.It is unknown which synthes device or devices were associated with these events; therefore, this report is for an unknown trauma device.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

The unreamed intramedullary locked nail and external fixator as it is unknown which synthes device or devices were associated with the reported events.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: 3749596
• MDR Text Key: 19295552
• Report Number: 2520274-2014-10764
• 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: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2014
• Is this an Adverse Event Report?: Yes
• 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: 04/02/2014
• 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