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

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

Patient Problems Hematoma (1884); Pain (1994); Discomfort (2330); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).This report is for an unk - constructs: matrixrib plate/screws/unknown 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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: peek, j.Et al.(2020), long-term quality of life and functional outcome after rib fracture fixation, european journal of trauma and emergency surgery, vol xx, pages 1-10 (switzerland) the primary aim of this study was to assess the long-term quality of life and functional outcome after rib fracture fixation for patients with multiple rib fractures or flail chest.Secondarily, this study sought to identify risk factors with impaired quality of life.Between january 2010 and december 2018, 74 patients with three or more rib fractures or a flail chest underwent plate osteosynthesis using the matrixrib system (depuy synthes).51 patients were additionally treated with intramedullary splints.The median age at trauma was 62 years and there were 63 male patients and 11 female patients with a mean age of 62 years.The long-term outcome measures were quality of life, level of dyspnea, return to work, implant irritation, and implant removal after a minimum of 12 months of follow-up.The following complications were reported: 7 patients were deceased.20 patients had pneumonia.1 patient had ards.2 patients had superficial wound infections.1 patient had revision surgery due to persistent hematoma.63 patients had pain/discomfort.6 patients experienced mild to severe complaints of dyspnea.23 patients had implant irritation.This report is for an unknown synthes matrixrib.This report is for (1) unk - constructs: matrixrib plate/screws.This report is 1 of 1 (b)(4).

• Brand Name: UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11670892
• MDR Text Key: 261749393
• Report Number: 8030965-2021-02930
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• 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: 04/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention