MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: TITANIUM STERNAL FIXATION PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown titanium sternal fixation/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal article: dell¿amore, a.Et al.(2020), sternal reconstruction after post-sternotomy dehiscence and mediastinitis, indian journal of thoracic and cardiovascular surgery, vol.36(4), pages 388-396 (italy).The aim of this work is to report our 8 years of experience in the surgical treatment of post-sternotomy dehiscence and mediastinitis.Between may 2010 and august 2018, a total of 237 patients who had post-sternotomy dehiscence were treated.Patients with a positive wound culture were treated with sternal resynthesis.Titanium plates/bars and screws (titanium sternal fixation system; depuy synthes, west chester, pa, usa) were used in 47 patients.Plastic sternal bands (zipfix; depuy synthes, west chester, pa, usa) were used in 11 patients.The following complications were reported as follows: 23 patients died because of cardiac complications in 8 patients, sepsis in 5 patients, respiratory failure in 5 patients, pulmonary embolism, major stroke, and multi-organ failure in 2 patients each, bowel ischemia in 1 patient.4 patients died due to: cardiac failure in 3 patients, major stroke in 1 patient.In 13 patients, the wound cultures were still positive, and 8 cases had the same microbial contamination.Vacuum-assisted closure (vac) therapy was reapplied in 9 patients for a mean time of 5.1 days ± 3 days (range 2¿9).All of these patients were re-operated after a mean time of 8.3 days ± 4.4 days (range 2¿17).This report is for an unknown synthes titanium sternal fixation.It captures the reported events of positive wound cultures and reoperation.This is report 3 of 4 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: TITANIUM STERNAL FIXATION PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12561845
• MDR Text Key: 274924098
• Report Number: 8030965-2021-08225
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• 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: 11/03/2021
• 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