MAUDE Adverse Event Report: SYNTHES USA; INSTRUMENT, BENDING OR CONTOURING

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

Patient Problems Pain (1994); Swelling (2091); Post Operative Wound Infection (2446)

Event Date 04/29/2011

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article: " sternal plate fixation for sternal wound reconstruction: initial experience (retrospective study) " by fawzy et al.Journal of cardiothoracic surgery 2011, 6:63 (1-7).The aim of this retrospective study is to evaluate the initial experience of a transverse plate fixation system following wound complications associated with sternal dehiscence with or without infection following cardiac surgery.Patients were considered for plate fixation after failure of the primary standard wire closure associated with wound dehiscence.There were 40 consecutive patients [the average age was 69.7 ± 9.4 years], 31 males and 9 females.Twenty two patients (55%) were diagnosed with sternal dehiscence alone and 18 patients (45%) with associated wound discharge.All patients underwent sternal fixation using three rib plates combined with a single manubrial plate (titanium sternal fixation system®, synthes).Postoperative wound complications included: one patient (2.5%) has post-operative bleeding.One patient (2.5%) developed postoperative seroma after 16 days.Six patients (15%) developed post-operative superficial wound dehiscence with discharge.They all subsequently healed.Four patients (10%) developed postoperative pleural effusion that was successfully drained by thoracocentesis.One patient (2.5%) developed post-operative pneumothorax that was drained by an intercostal chest tube.Two patients (5%) developed recurrent wound infection.One patient underwent hardware removal due to pain and one patient underwent hardware removal due to wound infection.There was one death unrelated to the sternal closure that had infective endocarditis of his prosthetic valve and died of refractory septic shock.This is report 1 of 1 for (b)(4).This report is for unknown (cmf) sternal plate fixation system.A copy of the journal article is being submitted with this medwatch.

Manufacturer Narrative

Device was used for treatment, not diagnosis." sternal plate fixation for sternal wound reconstruction: initial experience (retrospective study) " by fawzy et al.Journal of cardiothoracic surgery 2011, 6:63 (1-7).This report is for an unknown (cmf) sternal plate fixation system / unknown quantity / unknown lot.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: INSTRUMENT, BENDING OR CONTOURING
• 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: 4586748
• MDR Text Key: 5336932
• Report Number: 2520274-2015-11628
• Device Sequence Number: 1
• Product Code: HXP
• 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: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• 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
• Date Manufacturer Received: 02/20/2015
• 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