MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: 3.5 MM LCP PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problems Wound Dehiscence (1154); Fatigue (1849); Unspecified Infection (1930); Muscular Rigidity (1968); Non-union Bone Fracture (2369); Malunion of Bone (4529); Insufficient Information (4580)

Event Date 10/08/2022

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unk - constructs: 3.5 mm lcp plate/screws lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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.

Event Description

Device report from synthes reports an event in india as follows: this report is being filed after the review of the following journal article: kumar, r.Et al (2022), distal tibia fractures managed with locking compression plate osteosynthesis: a prospective study of 28 patients, international journal of pharmaceutical and clinical research vol.14 (10), pages 289-297 (india).The aim of this study was to evaluate clinical, functional and radiological outcomes after open reduction and internal fixation using distal tibial locking compression plate (lcp).Between september 2020 to august 2022 a total of 28 patients (19 male and 9 female) with a mean age of 37.7 years were included in the study.These patients had distal tibia fracture and were treated using aps (lcp metaphyseal plates 3.5, depuy synthes, us).20 of these patients had closed fracture while the remaining 8 had open fracture.All patients were followed up clinically and radiologically at 6-week intervals for the first three months and then every three months for a minimum of 12 months.The following complications were reported as follows: - 8 patients had infection: = 5 patients with simple infections, treated with antibiotics and regular antiseptic dressing; = 3 patients developed wound dehiscence and was treated with intravenous antibiotics as per culture & sensitivity report, debridement and wound coverage when good granulation tissue formed; - 4 patients with delayed union; - 2 patients had malunion; - 2 patients had nonunion, and underwent revision surgery with secondary bone grafting and ultimately healed with good functional outcome; - 6 patients had hardware problem (e.G.Irritation in skin); - 4 patiets had ankle stiffness; - 1 patient had reflex sympathetic dystrophy.This report is for an unknown synthes 3.5mm lcp.This is report 1 of 1 for complaint (b)(4).A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - CONSTRUCTS: 3.5 MM LCP PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18758030
• MDR Text Key: 335998305
• Report Number: 8030965-2024-02757
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• 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: 02/07/2024
• 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