MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problem Insufficient Information (4580)

Event Type  Death  

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 unknown matrixrib construct/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.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: niziolek, g.Et al (2022), ¿early results after initiation of a rib fixation programme: a propensity score matched analysis¿, injury, vol.53 (xx), pages 137¿144 (usa).The aim of this propensity score matched analysis is to compare non-operative management of patients with severe chest wall injury with those patients undergoing surgical stabilisation of rib fractures (ssrf).Over the period of study, a total of 45 patients underwent ssrf (all-ssrf).The first 22 patients from this cohort were used as described above for matching (early-ssrf).All patients undergoing ssrf were plated with the matrixrib fixation system (depuy synthes, raynham, ma).A total of 2,447 patients with blunt chest injury underwent propensity match analysis which, after screening for indications and contraindications, yielded 36 patients in the non-op cohort.The mean follow-up period was unknown.The following complications were reported as follows: 1 patient died/30-day mortality.21 patients had pulmonary complications: respiratory failure > 48 hours (n=19), pneumonia (n=12), acute respiratory distress syndrome (n=1), unplanned intubation (n=7).2 patients had cardiac complications: mi (n=2) and cardiac arrest (n=1).14 patients had infectious complications: pneumonia (n=12), wound infection (n=3), cauti (n=2).4 patients had 30-day readmission.1 patient from early-ssrf had their hardware removed at 9 months for pain from the hardware.This is report 2 of 2 for (b)(4).This report is for an unknown synthes matrixrib constructs.

• Brand Name: UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14980798
• MDR Text Key: 295671498
• Report Number: 2939274-2022-02596
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• 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: 06/13/2022
• 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): Death