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

Device Problem Migration (4003)

Patient Problems Pain (1994); Pocket Erosion (2013); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients.All known information is provided in the literature article.This report is for an unknown plate/unknown lot.Part and lot number are unknown; udi number is unknown.There are multiple unknown dates of implantation between august 2008 to december 2015.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.(b)(4).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:bazarov i., et al (2018),minimally invasive plate osteosynthesis for treatment of ankle fractures in high-risk patients ,the journal of foot & ankle surgery, volume 57 ,pages 494¿500 (usa).This study aims to report our experience using minimally invasive plate osteosynthesis (mipo) in the management of unstable ankle fractures in elderly patients, patients with a compromised soft tissue envelope, and those with medical comorbidities.From august 2008 to december 2015, a total of 44 patients (10 male and 34 female) age <60 =60 who had undergone surgical treatment of unstable ankle fractures using mipo technique were included in the study.All patients had received fixation with a combination of synthes plates and screws using the mipo technique most patients were followed up in the clinic at 10 to 14 days, 6 weeks, 8 weeks, and 3 months postoperatively.The mean follow-up period was 82 (range 52 to 293) weeks.The following complications were reported: complications occurred in 12 patients (27%).Eleven patients (25%) developed surgical wound dehiscence.Of these 11 patients, 7 healed with local wound care alone, and 1 developed a superficial infection and was successfully treated with oral antibiotics.1 patient had superficial infection.3 cases of deep infection.8 patients had additional surgery.3 patients had exposed hardware and required hardware removal and intravenous antibiotics.Hardware failure and loss of reduction occurred in 5 patients (11%).Of these 5 patients, 1 patient was treated with bracing, the syndesmotic screws were exchanged at 4 weeks postoperatively in 1 patient, and 3 patients developed significant ankle pain and eventually required ankle fusion.7 patients died.This report is for an unknown synthes plate.This is report 3 of 4 for (b)(4).

• Brand Name: UNK - PLATES
• 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: 9082155
• MDR Text Key: 163196288
• Report Number: 2939274-2019-60671
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2019
• 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