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

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

Patient Problems Injury (2348); Impaired Healing (2378); 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 and screw construct/unknown lot.Part and lot number are unknown; udi number is unknown.Date of implantation is an unknown date between may 2000 to may 2015.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.(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: degeorge jr., b.R., brogan, d.M., shin, a.Y.(2020), the relationship of volar plate position and flexor tendon rupture: should we question the validity of the soong classification, plastic and reconstructive surgery, vol.Xx (xx), pages 1-22 (usa).The aim of this retrospective study is to determine the reliability of the soong classification in predicting tendon-related issues in a single institution with a large cohort of patients.A secondary objective of the study was to investigate the relationship of the quality of the fracture reduction and the soong classification.Between may 2000 to may 2015, a total of 648 patients (659 fractures; 156 male and 503 female) with a mean age of 56.5 years (range, 18 to 93 years) were managed with volar locking plate fixation.Surgery was performed using a 2.4 mm volar distal radius plate (depuy synthes, west chester, pa) in 16.5% of patients and a competitor's device for the rest.The mean duration of clinical follow-up was 12.9 ± 0.7 months, with a range from 6.1 months to 12.3 years.The following complications were reported: 29 patients had an intra-articular step-off > 2 mm.80 patients had an inadequate fracture reduction.2 patients had flexor pollicis longus (fpl) tendon ruptures.6 patients had flexor tendinopathy (4 flexor pollicis longus and 2 flexor carpi radialis).7 of 50 patients, who required removal of asymptomatic hardware, had reported tendinopathy.This report is for an unknown synthes plate/screws constructs.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: 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: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10420084
• MDR Text Key: 205286493
• Report Number: 2939274-2020-03589
• 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: 07/24/2020

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: 07/24/2020
• Initial Date FDA Received: 08/18/2020
• 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