MAUDE Adverse Event Report: SYNTHES GMBH 10/125 DEG TI CANN TFNA 235/LEFT - SILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.037.015S
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
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.Additional narrative: investigation summary the product was not returned to j&j medtech orthopaedics, however x-rays were provided for review.The x-ray investigation revealed the sample is observed implanted over the right side leg of the patient.Product code provided information belongs to a left side nail implant.The reported condition can be confirmed.As per event details, potential cause can be traced to user; i was the one who checked the nail and gave the order to open it.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 10/125 deg ti cann tfna 235/left - sile 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.Device history manufacturing location: monument manufacturing date: 26-aug-2024 expiration date: 01-aug-2034 part number: 04.037.015s, 10mm/125 deg ti cann tfna 235mm/left ¿ sterile lot number: 31964p9 (sterile) lot quantity: (b)(4).A manufacturing record evaluation was performed for the finished device with batch number 31964p9.No nonconformities or manufacturing irregularities have identified related to the complaint condition.Component parts were not reviewed as the reported complaint condition of ¿affected side is the right but the nail that was used was for the left¿ does not indicate breakage of the nail or any of its components.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.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 on (b)(6) 2025, the patient underwent an unknown surgery on a trochanteric part with tfna.The surgery was completed successfully with no delay.However, sales rep got a phone call from the surgeon, and he said ¿the patient underwent tfna surgery on may 1st.The affected side is the right, but the nail was used was for the left.Is there any problem?¿ after checking the usage history, it was confirmed that the left nail was being used.The difference in nail shape and the associated risks were explained.

• Brand Name: 10/125 DEG TI CANN TFNA 235/LEFT - SILE
• 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 ; 9083863534
• MDR Report Key: 22509832
• Report Number: 8030965-2025-07154
• Device Sequence Number: 21143988
• Product Code: HSB
• UDI-Device Identifier: 10886982095732
• UDI-Public: (01)10886982095732(17)340801(10)31964P9
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.037.015S
• Device Lot Number: 31964P9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2024
• 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
• Patient Sex: Unknown