MAUDE Adverse Event Report: SYNTHES GMBH RFNA / 11MM / 360MM STANDARD BEND / STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.233.136S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/23/2025
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.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
It was reported that a patient presented to the er with proximal femoral pain.The patient previously had an osteosarcoma removed from their left midshaft femur and a large segment was replaced with an allograft femur and fixated with a depuy synthes rfna.At sometime postoperatively, the proximal end of the rfna had broken through one of the empty screw holes.The nail was removed and replaced with a 12x360mm standard bend rfna and a 18 hole va-lcp curved condylar plate.
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: h6: the photo was returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that the retrogr fem nail adv - rfn-adv ø11 l 360 is seen broken through one of the screw holes.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for retrogr fem nail adv - rfn-adv ø11 l 360.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot manufacturing location: monument manufacturing date: 08-aug-2023 expiration date: 30-jun-2028 part number: 04.233.136s, rfn/11mm/360mm std bend/pe inlay/sterile lot number: 7323p24 (sterile) lot quantity: (b)(4).Component part(s) reviewed: part number: 21131, tialv*ri13.00 lot number: 7227p10 qty: (b)(4) pounds.Part number: 04.233.124.2y, poly inlay, retrograde femoral lot number: 7099p15 lot quantity: (b)(4).Device history review a manufacturing record evaluation was performed for the finished device with batch number 7323p24.No nonconformities or manufacturing irregularities have identified related to the complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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: a2 (age) 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: 08-aug-2023 expiration date: 30-jun-2028 part number: 04.233.136s, rfn/11mm/360mm std bend/pe inlay/sterile lot number: 7323p24 (sterile) device history review = > a manufacturing record evaluation was performed for the finished device with batch number 7323p24.No nonconformities or manufacturing irregularities have identified related to the complaint condition.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 / 360MM STANDARD BEND / STERILE
• 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: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22467630
• Report Number: 8030965-2025-06969
• Device Sequence Number: 4272749
• Product Code: HSB
• UDI-Device Identifier: 10886982290663
• UDI-Public: (01)10886982290663(17)280630(10)7323P24
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K201346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.233.136S
• Device Lot Number: 7323P24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 08/19/2025; 08/22/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 08/19/2025; 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2023
• 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: 16 YR
• Patient Sex: Female