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); Non-union Bone Fracture (2369)

Event Date 08/29/2023

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.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) italy 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 italy as follows: this report is being filed after the review of the following journal article: gilli, a.Et al (2023), do working length and proximal screw density influence the velocity of callus formation in distal tibia fractures treated with a medial bridge plate?, european journal of orthopaedic surgery & traumatology xx.Xx, pages 1-6 (italy).The aim of this retrospective study is to analyze the influence of working length and screw density on distal tibia fractures fixed with a medial bridge plate.Between january 2014 to december 2019, a total of 42 patients (30 male and 12 female) with a mean age of 55.3 years, and a minimum of 1 year follow up were included in the study.These patients were treated for distal tibia fractures with a medial bridge plate using the same plate (lcp metaphyseal plate for distal medial tibia 3.5¿4.5, depuy synthes, warsaw, in) in all patients but in different sizes.Early signs of callus formation were assessed through post operative radiographs with an mrust (modified radiographic union scale for tibial fractures) score.32 patients had an mrust >8, while the other ten had an mrust <8.A total of 39 fractures healed uneventfully, while 3 patients did not (2 of these 3 patients healed at 1 year follow up while 1 was lost at follow up).The following complications were reported as follows: - 1 patient had a nonunion; - 2 patients had infection and required further medical procedures.This report is for an unknown synthes lcp metaphyseal plate.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: 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: 18747461
• MDR Text Key: 335872746
• Report Number: 8030965-2024-02681
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• 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: 02/06/2024
• 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