MAUDE Adverse Event Report: SYNTHES GMBH UNK - ELASTIC NAILS: TITANIUM; PIN, FIXATION, SMOOTH

Catalog Number UNK - ELASTIC NAILS: TITANIUM

Device Problem Migration (4003)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/07/2022

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 unknown elastic nails: titanium/unknown lot.Part and lot numbers are unknown; udi 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.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 croatia as follows: this report is being filed after the review of the following journal article: pogorelic, z.Et al., (2022), elastic stable intramedullary nailing for treatment of pediatric tibial fractures: a 20-year single center experience of 132 cases, children., vol.9 (845) pages 1-12.(croatia).The aim of this retrospective cross-sectional cohort study was to analyze the outcomes and complications in children treated with elastic stable intramedullary nailing (esin) for tibial fractures.Between march 2002 to march 2022, a total of 132 patients (92 males and 40 females with a median age of 12 years) were treated with esin for displaced tibial shaft fractures or dia-metaphyseal distal tibial fractures.For the purpose of this study, the patients were subdivided in two subgroups regarding the localization of the fracture.The patients from the first subgroup had a tibial shaft fracture, while the patients from the second group had a distal tibial fracture.This study was treated with titanium intramedullary nails (ten; synthes).The median follow-up was 118.5 months.The following complications were reported as follows: - a total of 6 (4.5%) patients required reoperation due to angulation of the fragments (n = 5) or refracture (n = 1).- 2 malunions, 4 delayed unions, 3 limb shortening, 2 limb lengthening, 2 superficial infections on the nail entry site.However, none of their patients required secondary surgical intervention due to those complications.- 15 (11.36%) patients, which included 5 angulations of the fragments, 4 entry site irritations, 2 protrusions of the nails, 2 skin blisters, 1 pseudoaneurysm, and 1 refracture.This report is for unknown titanium intramedullary nails (ten; synthes® gmbh, oberdorf, switzerland).This is report 2 of 2 for complaint (b)(4).

• Brand Name: UNK - ELASTIC NAILS: TITANIUM
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 16280635
• MDR Text Key: 308606809
• Report Number: 8030965-2023-01277
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: HR
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - ELASTIC NAILS: TITANIUM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 02/01/2023
• 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