MAUDE Adverse Event Report: SYNTHES GMBH TFNA FEM NAIL Ø10 130° L200 TIMO15; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.037.043S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/14/2025
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.Additional narrative: h6: photo investigation: the product was not returned to j&j medtech orthopaedics; however x-rays were provided for review.The x-ray investigation revealed the nail was broken in two fragments from the distal locking screw hole.The observed condition of the device was consistent with a component failure that was most likely caused by exposure to unintended forces as mentioned on the event description: patient had a fall and fractured at the distal locking screw.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.The overall complaint was confirmed as the observed condition of the tfna fem nail ø10 130° l200 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 j&j medtech orthopaedics 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.H3, h4, h6: device history record (dhr) review conducted: part: 04.037.043s.Lot: 42640p2.Manufacturing site: werk selzach.Supplier: (b)(4).Release to warehouse date: 11 nov 2024.Expiration date: 01 nov 2034.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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
It was reported that the patient had a short tfna inserted this year within the last 6 months.Original surgeon wanted to insert long nail but patient was unwell due to anaesthetic complications and not due to fracture related.Therefore surgeon was asked to be quick and if he could insert a short nail instead.Patient had a fall and fractured at the distal locking screw of nail postoperatively.The short tfna was removed and long tfna was inserted with traumacem.Ria2 was used to irrigate and harvest bone graft.Proximal femur ppfx plate used to supplement fixation.

• Brand Name: TFNA FEM NAIL Ø10 130° L200 TIMO15
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: elba bello ; 1302 wrights lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22948325
• Report Number: 8030965-2025-08919
• Device Sequence Number: 9062488
• Product Code: HSB
• UDI-Device Identifier: 10886982095992
• UDI-Public: (01)10886982095992(17)341101(10)42640P2
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• 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: 04.037.043S
• Device Lot Number: 42640P2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2024
• 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: 75 YR
• Patient Sex: Unknown