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

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

Patient Problems Unspecified Infection (1930); Pneumonia (2011); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown matrixrib plates/ 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.(b)(4).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.(b)(4).

Event Description

This report is being filed after the review of the following journal article junker, m.S.Et al (2019), salvage of rib stabilization hardware with antibiotic beads, the american journal of surgery, vol 218 (5), pages 869-875, (usa).The aim of this single institution retrospective study is to assess the use of antibiotic beads in patients with ssrf hardware infections, hypothesizing that the addition antibiotic beads would suppress infection and permit bony union.Between august 2009 to may 2017, a total of 285 patients (194 male and 91 female) with a mean age of 61 ± 17 years underwent surgical stabilization of rib fractures (ssrf).Surgery was performed using the matrixrib fixation system (synthes, west chester, pa, usa) or a competitor's device.Infected and at-risk hardware were managed with antibiotic beads.The follow-up period was unknown.The following complications were reported as follows: 5 patients died due to withdrawal of organ support in the setting of chronic respiratory failure (n = 4) and cerebrovascular accident (n = 1).47 patients had perioperative pneumonia.146 patients had mechanical ventilation.10 patients developed hardware infection.5 patients developed acute kidney injury (aki).21 patients had tracheostomy.Prophylactic bead group: 1 patient required a chest tube postoperatively.2 patients have had their beads removed, but hardware remains in place secondary to difficult access for removal (u-plates that are deep to the scapula).Infection bead group: 1 patient required chest tube placement at the time of hardware removal.This report is for an unknown synthes matrixrib plates.It captures the following adverse events: perioperative pneumonia, developed hardware infection, developed acute kidney injury had tracheostomy, required a chest tube postoperatively/ at the time of hardware removal and difficult removal of hardware.This is report 1 of 2 for complaint (b)(4).

• Brand Name: UNK - PLATES: MATRIXRIB
• 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: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10076818
• MDR Text Key: 192040941
• Report Number: 2939274-2020-02471
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 05/20/2020
• 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