MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 75MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71645075
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known risks with the device itself or with its use that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, after femoral nailing following a high energy injury on (b)(6) 2023, the patient had a bone defect.Then, on (b)(6) 2024 two distal screws were removed to allow dynamization.The patient recently experience pain and an x-ray showed a broken distal screw.This adverse event was treated by a revision surgery on (b)(6) 2025, in which the nail has been replace and bone graft has been placed to address the bone defect.Current health status of the patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).Additional information: h6:health effect - clinical code and type of investigation correction: d1: brand name, d2a: common device name, d2b: procode, d4: catalog#, lot#, expiration date, unique device identifier (udi)#,d10: concomitant medical products and therapy dates, g4: pma/510(k) #, h4: device manufacture date h11:the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the available information, the clinical root cause cannot be confirmed.Patient factors such as the initial high-energy injury and bone defect may have contributed, and prolonged fracture healing suggests possible fatigue stress on the nail.No evidence indicates device malfunction.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for trigen intertan nail system revealed that preoperative revealed that the following factors should be considered: a patient¿s size, strength, skeletal characteristics, skeletal health, and general health.Overweight or musculoskeletal deficient or unhealthy patients may create greater loads on implants that may lead to breakage or other failure of the implants and whether a patient has a degenerative or progressive disease that delays or prevents healing and consequently decreases the effective life of the implant.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.According with inspection drawing, the final inspection includes the verification of part configuration per print.Also, per material specification, the quality and manufacture of standard grade titanium-6 aluminum-4 vanadium alloy shall be controlled.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include patient anatomy, abnormal loading of limb, excessive forces and/or injury.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: TRIGEN LOW PROFILE SCREW 5.0MM X 75MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23704741
• Report Number: 1020279-2025-02001
• Device Sequence Number: 16132395
• Product Code: HSB
• UDI-Device Identifier: 00885556216491
• UDI-Public: 885556216491
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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: 71645075
• Device Lot Number: 21MM05178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 71645075; 71675537; INTERTAN 10S 10MM X 40CM 125D RIGHT, LOT#:21GSM039; LAG/COMP SCREW KIT 90/85, LOT:22AT58367
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 81 KG