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

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

Patient Problems Pulmonary Embolism (1498); Unspecified Infection (1930); Pneumonia (2011); Post Operative Wound Infection (2446)

Event Date 06/03/2022

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unk - constructs: matrixrib plate/screws lot.Part and lot numbers are unknown; udi 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

Hold 2.7 it device report from synthes reports an event in netherlands as follows: this report is being filed after the review of the following journal article: van gool, m.H.Et al.(2022), vats-assisted surgical stabilization of rib fractures in flail chest: 1-year follow-up of 105 case, general thoracic and cardiovascular surgery, vol 70, pages 985-992 (netherlands) this study analyzed the outcome of our 7-year experience with video-assisted thoracoscopic surgery (vats)-assisted surgical stabilization of rib fractures (ssrf) for flail chest.From january 2013 to december 2019, vats-assisted ssrf for flail chest was performed in 105 patients (81 male, 24 female).Median age was 65 years (range 21¿92).The ssrf was performed with matrix rib fixation system (depuy synthes, amersfoort, the netherlands).For this report follow-up data was analyzed from date of vats-assisted ssrf to 1-year post-operative.The following complications were reported as follows: complications during admission: grade i: (n=3) surgical site infection.(n=3) ileus without tpn.(n=1) hip contusion caused by a fall.(n=1) electrolyte disorder.Grade ii: (n=13) pneumonia.(n=7) delirium.(n=3) other infections.(n=2) atrial fibrillation.(n=2) exacerbation copd.(n=1) hypertension.(n=1) epileptic insult.Grade iii: (n=1) this patient (male; aged 60; history of pulmonary emphysema) needed prolonged mechanical ventilation, and underwent a pleurodesis for prolonged air leakage at day 14 postsurgery.Grade iv: (n=1) patient (male; aged 74; asa 3 based on hypertension, atrial fibrillation and copd; iss 16) was reintubated on the icu 1 day after surgery because of respiratory failure (cdc grade iv complication).This patient recovered without further complications and was alive and in good health at 1-year follow-up.Grade v: (n=1) death.This concerned an 87-year-old patient who died due to respiratory failure during admission on the icu (cdc grade v complication).He had a history of myocardial infarction, chronic renal failure and multiple transient ischemic attacks.Complications after discharge: grade i: (n=2) surgical site infection.Grade ii: 1 patient was readmitted for intravenous antibiotics for the treatment of a pneumonia at day 16 after surgery (cdc grade ii).(n=1) pulmonary embolism.Grade iii: 1 patient had a deep ssi (cdc grade iii) at day 28 after surgery which required surgical treatment.1 patient was readmitted for a dislocated intramedullary splint that was removed with vats at day 40 (cdc grade iii).6 other patients died after discharge of causes not related to the trauma.In these patients the cause of death was related to: esophageal cancer (n = 1, 334 day postoperative), cerebral abscess (n = 1, 308 day postoperative), liver cancer (n = 1, 101 day postoperative), aspiration pneumonia (n = 1, 70 day postoperative), gastric bleeding (n = 1, 64 day postoperative) and cerebrovascular accident (n = 1, 40 day postoperative).This report is for an unknown synthes matrix rib.This is report 3 of 3 for complaint (b)(4).A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16312323
• MDR Text Key: 308959116
• Report Number: 8030965-2023-01488
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• 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: 01/13/2023
• 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