MAUDE Adverse Event Report: SYNTHES USA

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This device used for treatment and not diagnosis.This report is on an unknown humerousblock device, part and lot numbers are unknown.Date of event: 2012.Relevant tests/lab data: x-rays included: anterior-posterior the scapular plane, outlet view and auxilliary view and bilateral ct scan.Post-operative x-rays included anterior-posterior, outlet and velpeau views and were performed immediately postoperatively and at 3, 6, 12 and 24 weeks after surgery.If fracture lines were still visible after 24 weeks additional x-rays were made after 9 months and after 1 year.Without a part number the 510k number cannot be provided.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.

Event Description

Journal article received: predicting failure after surgical fixation of proximal humerus fractures: injury, 2011 elsevier: dietmar krappinger, nicola bizzotto, stephan riedmann, christian kammerlander, clemens hengg, franz sebastian kralinger.This article does mention synthes product.Study was to asses risk factors for failure after surgical fixation of unstable proximal humerus fractures in a multivariate set up.Two surgical techniques were used: philos locking plate and humerusblock were used.Sixty seven patients included in the study with a mean age of 63.9.In the philos group every kind of postoperative relative movement between the implant and the humeral head or shaft was defined as failure.In the humerusblock group, postoperative movement between the humeral head and the shaft in terms of angulation or translational displacement was defined as a failure.There was no significant differences in age, gender, local bmd and fracture type between the humerusblock and philos group.Preoperative assessment of local bmd and patients age as well as intraoperative anatomic reduction and restoration of the medial cortical support are the essentials for successful surgical fixation of the proximal humerus fractures.Event: two patients from the humerusblock group underwent open reduction and plate fixation.This report is on the humerousblock device.This is 1 of 1 report for (b)(4).

• Manufacturer (Section D): SYNTHES USA; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3643332
• MDR Text Key: 15879069
• Report Number: 2520274-2014-00743
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2014

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?: No
• Initial Date Manufacturer Received: 01/29/2014
• Initial Date FDA Received: 02/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention