MAUDE Adverse Event Report: SYNTHES GMBH RFNA/ 11MM/ 420MM/ STANDARD BEND/ STER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.233.142S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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
Study id: (b)(6) subject id: (b)(6).Clinical adverse event received for knee pain device and procedure (relatedness) device related: no information provided procedure related: no information provided date of event: 12 feb 2025.Date of implant: (b)(6) 2024.Date of revision: no information provided.Device location: right.Treatment/impact: hospitalization and surgical intervention at the fracture site.Depuy synthes products used: catalog number: 04.233.142s lot number: 3412p36 component type: rfna description: retrograde femoral nail advanced: 11mm: length 420mm.Catalog number: 02.233.100s lot number: no information provided component type: locking attachment washer: right description: no information provided.Catalog number: no information provided lot number: no information provided component type: were locking screws description: no information provided.Catalog number: no information provided lot number: no information provided component type: were locking screws description: no information provided.Catalog number: no information provided lot number: no information provided component type: were locking screws description: no information provided.Catalog number: no information provided lot number: no information provided component type: were locking screws description: no information provided.Catalog number: no information provided lot number: no information provided component type: were 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.H11 additional narrative: added: d10.Corrected: d4 (expiration date, udi).H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.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.Device history review: manufacturing location: monument.Manufacturing date: 18-dec-2022, expiration date: 30-n0v-2027, part number: 04.233.142s-us, rfn/11mm/420mm std bend/pe inlay/sterile, lot number: 3412p36.Device history review: this lot met all dimensional, visual, sterilization and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received: device related: possible.Procedure related: probable.Date of revision: on (b)(6) 2025.Treatment/impact: revision, involving adjustment, modification, removal or replacement of any registry nail system components.
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: added: b5 and d6b.Corrected: h6 (health effect - impact code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: RFNA/ 11MM/ 420MM/ STANDARD BEND/ STER
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 21883232
• Report Number: 8030965-2025-03858
• Device Sequence Number: 8742013
• Product Code: HSB
• UDI-Device Identifier: 10886982290694
• UDI-Public: (01)10886982290694(17)271130(10)3412P36
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233696
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 04/22/2025

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: 04.233.142S
• Device Lot Number: 3412P36
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 04/30/2025; 05/28/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 05/01/2025; 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LCKNG ATTACH WASHER RFNA / 5 DEG/ RT/ S; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown