MAUDE Adverse Event Report: Synthes GmbH TFN-ADVANCE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.037.255S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent revision surgery due to material failure with proximal migration of the tfna helical blade despite locking.Upon manufacturers investigation it was noted that the returned nail revealed that the connection between the nail and the connecting screw was stripped and one the prongs was broken.
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.H11.Additional manufacturer narrative: h3, h6: manufacturing location: monument.Manufacturing date: 07-jul-2025.Expiration date: 01- jul -2035.Part number: 04.037.255s, 12mm/130 deg ti cann tfna 340mm/leftt- sterile.Lot number: 74441p3 (sterile).A manufacturing record evaluation was performed for the finished device with batch number 74441p3.No nonconformities or manufacturing irregularities have identified related to the complaint condition.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device revealed that the connection between the nail and the connecting screw was stripped and showed evidence of metal wear.These observations are consistent with contact and interaction between the mating threads.Additionally, the prong of the locking screw was found to be broken.The broken fragment was not returned for evaluation.The fracture surface was thoroughly examined and no problems with the material were noted.In addition, unknown material, which may be organic material, was observed on the device and may have adhered during the implantation attempt.However, a complete potential cause cannot be established.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.A dimensional inspection for the tfna fem nail ø12 le 130° l340 timo15 was not performed due to post manufacturing damage.A functional test was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the tfna fem nail ø12 le 130° l340 timo15 would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• Brand Name: TFN-ADVANCE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): Synthes GmbH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): Monument; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50852989
• Report Number: 8030965-2026-09622
• Device Sequence Number: 15959135
• Product Code: HSB
• UDI-Device Identifier: 10886982097354
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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
• Operator of Device: Health Professional
• Device Catalogue Number: 04.037.255S
• Device Lot Number: 74441P3
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2025
• 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 Sex: Female