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

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

Patient Problems Arthritis (1723); Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown - plates/unknown lot number.Without the specific part number, the udi number and 510k 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 as no product was received.The investigation could not be completed; 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: j.Sebastiaan souer el.Al (2009), comparison of ao type-b and type-c volar shearing fractures of the distal part of the radius, the journal of bone & joint surgery vol.91(11), pages 2605-2611 (usa) doi:10.2106/jbjs.H.01479.The aim of this article is to investigate the relative incidence of volar marginal articular fractures with and without a concomitant fracture of the dorsal metaphyseal cortex (i.E., we compared type-b and type-c oblique volar marginal articular fractures with volar radiocarpal subluxation) and tested the null hypothesis that there is no difference between these two fractures with regard to wrist function or health status after open reduction and plate-and-screw fixation.Between 2001 to 2004, type b- volar shearing fractures with a total of 20 patients (11 male and 9 female) with a mean age of 49 years (ranges 20-80 years) were included in the study.11 fractures were treated with a 2.4 mm locking compression plate, 5 patients were treated with 3.5-mm locking compression plate, and 2 patients treated with t-shape nonlocking plate.The mean duration of follow-up was unknown.The following complications were reported as follows: 2 patients had an intra-articular step-off base on radiographic evaluation at the 2 year follow-up.Grade-1 radiocarpal arthritis was found in 7 patients.Grade -2 radiocarpal arthritis was found in 2 patients.This report is for a synthes 2.4 mm locking compression plate (lcp), 3.5 mm locking compression plate (lcp) synthes titanium t-shaped nonlocking plate and stainless t-shaped nonlocking plate.This ips captures the following complications: 2 patients had an intra-articular step-off base on radiographic evaluation at the 2 year follow-up.Grade-1 radiocarpal arthritis was found in 7 patients.Grade -2 radiocarpal arthritis was found in 2 patients.This report is for one (1) unk - plates this is report 1 of 8 for (b)(4).

• 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: 8613878
• MDR Text Key: 145222408
• Report Number: 2939274-2019-58069
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• 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: 04/16/2019
• 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