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

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

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

A total of 36 patient patients (22 males and 14 females) with an average age of 48.2 years (range: 22-91 years) underwent fixed angle plate fixation.This report is for an unknown 2.7mm mini-fragment locking plate/unknown lot.Part and lot number 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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: moor, t.Et al.(2018), fixed angle plate fixation of comminuted patellar fractures, injury, vol.49, issue 6, pages 1203-1207 (usa).The purpose of this study was to evaluate radiographic, clinical and functional outcome of comminuted patella fractures treated with a fixed angle locking plates.A total of 36 patient patients (22 males and 14 females) with an average age of 48.2 years (range: 22-91 years) underwent fixed angle plate fixation.In 22 cases, the variable angle 2.4/2.7 mm x-plate (synthes, west chester, pa) was used.Other implants included various 2.4 and 2.7 mm plates from the locking mini-fragment sets (synthes, west chester, pa and smith & nephew, memphis, tn).The average length of follow-up was 154 weeks (range 12-297 weeks).The following complications were reported as follows: 4 patients had hardware irritation after 12 weeks.Additional complaints for this article are captured on related complaint (b)(4).This report is for an unknown 2.7mm mini-fragment locking plate.This is report 1 of 8 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: 9027011
• MDR Text Key: 162801097
• Report Number: 2939274-2019-60509
• 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: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• 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: 08/15/2019
• 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