MAUDE Adverse Event Report: SYNTHES GMBH TFNA SCR PERF L75 TAN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.038.175S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Physical Asymmetry (4573)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had a tfna implanted on the (b)(6) 2024.The tfna screw was exchanged on the (b)(6) 2025 due to pain.Since then, the femoral neck has collapsed with significant shortening.The tfna is now being removed and revised to a hemiarthroplasty.The surgeon has acknowledged this is not an implant failure, but a result of the patient¿s bone physiology.
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.H10 additional narrative: h3, h4, h6 investigation summary.The product was not returned to j&j medtech orthopaedics, however photos were provided for review.The photo investigation revealed nothing indicative of a device nonconformance.Device was observed implanted and no defect was identified.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 not confirmed as the observed condition of the tfna fem nail ø10 130° l200 timo15 would have not contributed to the reported adverse event.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 lot: the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: TFNA SCR PERF L75 TAN
• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 22199499
• Report Number: 8030965-2025-05904
• Device Sequence Number: 17864320
• Product Code: HSB
• UDI-Device Identifier: 10886982098672
• UDI-Public: (01)10886982098672
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 06/12/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.038.175S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female