MAUDE Adverse Event Report: SYNTHES GMBH END-CAP F/TFNA 0; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.045.870S
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
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: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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 orif for femoral trochanteric fracture with the end cap.A tfna operation was performed, but the end cap could not be connected to the xl40 driver, so the surgery was completed successfully with no delay with using another end cap.After the surgery, an inspection of the end cap revealed that the shape of the head inside was different from the other end caps.No further information is available.
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.H11 additional narrative: added: d9 corrected: e1 (facility name) the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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: d4 (expiry date), h4 corrected: d4 (primary udi number) h3, h4, h6: the product and a picture were returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the evidence provided.Visual analysis of the photo under attachment photo_(b)(4) (b)(6), (tr202510994 and tr202510994_local letter revealed scratches at the strardrive feature.As per visual analysis of the returned sample revealed the same condition observed on the visual evidence provided, the stardrive feature of the end-cap f/tfna 0 was noted with scratches.A complete potential cause can not be determined with the evidence provided.A dimensional inspection for the end-cap f/tfna 0 was not performed due to post manufacturing damage.An interactional test was performed using a screwdriver (part number 03.037.028) and was able to connect properly, however as the mating tfna was not received, a complete interaction was not possible.Per the tfn-advanced proximal femoral nailing system (tfna) surgical technique guide the following statement: inserting the 0 mm end cap remove the connecting screw using the ball hexagonal screwdriver with spherical head while leaving the insertion handle connected to the nail.Insert the 0 mm end cap using the stardrive screwdriver through the insertion handle.A guide wire can be used to help ensure alignment while inserting the end cap.After the end cap is inserted, remove the insertion handle from the nail.The overall complaint was confirmed as the observed condition of the end-cap f/tfna 0 would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.There is no indication that a design or manufacturing issue has caused the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review (dhr): a manufacturing record evaluation was performed for the finished device product code: 04.045.870s-us lot number: 80454p8 it was electronically reviewed and no nonconformances/manufacturing irregularities were identified during the manufacturing process.The product was released on: 09 sep 2025 manufacturing site: jabil bettlach expiry date: 01 sep 2035.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: END-CAP F/TFNA 0
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 23920758
• Report Number: 8030965-2025-13050
• Device Sequence Number: 15706496
• Product Code: HSB
• UDI-Device Identifier: 10886982296054
• UDI-Public: (01)10886982296054(17)350901(10)80454P8
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup,Followup

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: 04.045.870S
• Device Lot Number: 80454P8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 01/14/2026; 01/30/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/16/2026; 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2025
• 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
• Patient Sex: Unknown