MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LCP METAPHYSEAL PLATE; PLATE, FIXATION, BONE

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

Patient Problems Unspecified Infection (1930); Necrosis (1971)

Event Date 03/30/2022

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.H10 additional narrative: d1, d2, d3, d4, g5 ¿ 510k: this report is for an unk - constructs: lcp metaphyseal plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1: (b)(6).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.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.

Event Description

Device report from synthes reports an event in china as follows: this report is being filed after the review of the following journal article: liu, z.Et al (2022), effects of full-threaded headless cannulated compression screws and anatomical plates on the efficacy, safety, and prognosis of patients with triplane fractures of the distal tibia, am j transl res vol.14 (3), pages1714-1720 (china).This study aimed to compare the clinical efficacy, safety, and prognosis of full-threaded headless cannulated compression screws (hccss) and anatomical plates (aps) in the treatment of triplane fractures of the distal tibia.Between april 2017 to march 2019, a total of 74 patients (42 male and 32 female) with a mean age of 14.43 years, were included in this retrospective study.All patients had triplane fractures of the distal tibia.Patients were then divided into two groups base on the treatment received: research group (rg) with 38 patients (23 male and 15 female), a mean age of 14.19 years, receiving full-threaded hccss (cat.No 03.226.000, depuy synthes, us), and the control group (cg) with 36 patients (19 male and 17 female), a mean age of 14.67 years, receiving aps (lcp metaphyseal plates 3.5, depuy synthes, us).All patients were followed up to 6 months.The following complications were reported as follows: rg group: 1 patient with looseness of internal fixation.Cg group: 3 patients had infection, 1 patient had skin necrosis, 1 patient had looseness of internal fixation, 2 patient had rupture of internal fixation.This report is for an unknown synthes headless compression screw, and unknown synthes 3.5mm metaphyseal lcp.This is report 1 of 5 for complaint (b)(4).A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - CONSTRUCTS: LCP METAPHYSEAL PLATE
• 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: 18769190
• MDR Text Key: 336186512
• Report Number: 8030965-2024-02836
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• 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: 03/21/2024
• 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