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

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

Patient Problems Unspecified Infection (1930); Skin Erosion (2075)

Event Type  Injury  

Manufacturer Narrative

Multiple patient involved.Implantation date unknown.510k: this report is for an unk - screws: matrixrib/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: drahos a, nowack t, fitzgerald, christie db (2018), long-term postoperative hardware complications after open rib fixation, the american surgeon, volume 84, page e317-e319, (usa).The aim of our review is to provide long-term data from our institution regarding the incidence of these complications.From april 2009 through july 2017, 156 patients who underwent rib fixation were included in the study.There were 150 patients who were implanted with an unknown synthes matrix rib fixation system while the rest were implanted with 3 other competitors¿ devices.A total of 126 of 156 patients were at least one year postoperative, and only 96 had available radiographs for review; average time to radiograph was 11.8 months (min=six months, max=47.6 years).A total of 46 of 126 patients had available imaging one year or more after time of initial operation.Complications were reported as follows: 2 patients had hardware explantation because of infection.1 was identified at 7.5 months and the other at 3 years.1 patient had developed a chronic draining sinus from the chest wall while the other patient had an exposed plate after an overlying soft tissue infection had resulted in a wound dehiscence.The hardware in both cases was removed uneventfully and the patients recovered without further complications.This report is for the unknown synthes matrix rib fixation system.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - SCREWS: MATRIXRIB
• Type of Device: SCREW,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: 10047454
• MDR Text Key: 195235835
• Report Number: 2939274-2020-02308
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• 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: 04/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention