MAUDE Adverse Event Report: SYNTHES GMBH TIBIAL NAIL ADVANCED Ø10 L 345; NAIL, FIXATION, BONE

Catalog Number	04.043.235S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Subject id: (b)(6).Study no: (b)(4).Clinical adverse event received for deep vein thrombosis resulting in pulmonary embolism device related: no information provided.Procedure related: no information provided.Date of event: 08-aug-2023.Date of implant: (b)(6) 2023.Date of revision: no information provided.Device location: left.Treatment/impact: required in-patient hospitalization or prolongation of existing hospitalization, oral/topical medication (eliquis).Treatment/impact: outcome: recovered/resolved.Depuy synthes products used: catalog number: 04.043.235s.Lot number: 3743p43.Component type: tibial nail.Description: tibial nail-advanced / 10mm 345mm / sterile.Catalog number: no information provided.Lot number: no information provided.Component type: locking screws.Description: no information provided.Catalog number: no information provided.Lot number: no information provided.Component type: low profile locking screws.Description: no information provided.Catalog number: no information provided.Lot number: no information provided.Component type: low profile locking screws.Description: no information provided.Catalog number: no information provided.Lot number: no information provided.Component type: low profile locking screws.Description: no information provided.Catalog number: no information provided.Lot number: no information provided.Component type: low profile locking screws.Description: no information provided.
Additional 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.H11 additional narrative: corrected: h4.H3, h6: product was not returned.Based on the information available, it has been determined that no corrective and 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 history review (dhr): a manufacturing record evaluation was performed for the finished device.Product code: 04.043.235s-us.Lot number: 3743p43.It was electronically reviewed and no nonconformances/manufacturing irregularities were identified during the manufacturing process.The product was released on: 19 jan 2023.Manufacturing site: jabil bettlach.Expiry date: 31 dec 2032.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TIBIAL NAIL ADVANCED Ø10 L 345
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 23770920
• Report Number: 8030965-2025-12339
• Device Sequence Number: 18799407
• Product Code: JDS
• UDI-Device Identifier: 10886982297785
• UDI-Public: (01)10886982297785(17)321231(10)3743P43
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 04.043.235S
• Device Lot Number: 3743P43
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Race: White