MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 50MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71645050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after an internal fixation surgery had been performed approximately three months ago, the patient experienced a breakage of the intertan 1.5 11.5 mm x 42 cm 130d lt and the trigen low profile screw 5.0 mm x 30 mm.This adverse event was treated by a revision surgery on (b)(6) 2025, in which one (1) intertan 1.5 11.5 mm x 42 cm 130d lt, one (1) intertan 1.5 11.5 mm x 42 cm 130d lt, one (1) intertan subtroc lag 11 x 95 and one (1) trigen low profile screw 5.0 mm x 30 mm were explanted.Current health status of the patient is unknown.
Additional Manufacturer Narrative
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 inherent device and/or procedural risks 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 alter the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device concluded the device presents with the distal end fractured off and not returned; wear from use, with the markings degraded, the surfaces discolored, scratched and scuffed.The clinical/medical investigation concluded that, the provided photos confirm the nail fracture at the proximal lag screw hole and a single fractured distal screw.Additionally noted are what appears to be guide pins along with the explanted left im nail.The photocopied x-rays appear to support the complaint; however, the initial fracture type/location cannot be determined¿only that there is a subtrochanteric lag screw proximally and one screw distally in an unidentified fracture type/location with the long im nail.The requested clinical documentation/operative reports were not provided.The ifu includes indications, precautions/warnings and adverse events including implant fracture as well as the device does not replace normal healthy bone and may become damaged as a result of strenuous activity/obesity/trauma/etc.The post-operative instructions/adherence/activity and current health status of the patient are unknown.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.A clinical root cause could not be determined.Based on the photocopied imaging, the indications for use and utilization of appropriate products and techniques cannot be assessed/confirmed.Surgical technique/procedural variance, along with mechanical and/or patient factors cannot be ruled out as potential contributing factors to the reported event.The patient impact beyond the reported implant breakage and single distal screw and revision could not be determined.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 revealed similar events for the listed part number over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.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 size selected, surgical technique, postoperative care, patient anatomy, abnormal loading of limb, excessive forces and/or injury.Based on this investigation, the need for corrective action is not indicated.Should 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.
Additional Manufacturer Narrative
H10: data was corrected in section d1, d4 and g4.

• Brand Name: TRIGEN LOW PROFILE SCREW 5.0MM X 50MM
• 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: 23956964
• Report Number: 1020279-2026-00011
• Device Sequence Number: 12164824
• Product Code: HSB
• UDI-Device Identifier: 00885556215999
• UDI-Public: 885556215999
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2026

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: Lay User/Patient
• Device Catalogue Number: 71645050
• Device Lot Number: 25AM09266
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 01/30/2026; 02/02/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 01/30/2026; 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71678095/LOT NUMBER 22KT68XX
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown