MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMART FX STRUT MEDIUM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	71075720
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an external fixation surgery performed on (b)(6) 2025, one (1) smart fx strut medium collapsed under load.This issue was solved the same day ((b)(6) 2025) by replacing the smart fx strut medium with a s+n device.The current health status of the patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).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 relates to known inherent device and/or procedural risks 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.At this moment, smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
The associated device was returned and evaluated.The visual inspection revealed that no adjustment bands returned with the device, the device is worn from use with no visible defect.A functional evaluation could not be completed since an incomplete device was returned.The clinical/medical investigation concluded that, based on the limited information provided, the clinical root cause of the reported issue cannot be determined.We are unable to rule out improper size selection, improper device positioning, and improper fixation as possible contributory factors.There is no evidence to support that there was a device malfunction.The patient's current condition is unknown and the patient impact beyond the reported events 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 surgical technique for smart tsf revealed that the acute adjustment band keeps the strut in fully adjustable mode.Removing the band puts the strut in gradual mode.Acute adjustability can still be achieved by pressing the acute adjustment button or re-attaching the acute adjustment band.The id band covers the acute adjustment button to prevent the strut being inadvertently adjusted acutely outside of the operating room.Gradual adjustments are performed by turning the patient adjustment dial.Id bands designate the strut number and prevent the patient from performing an acute adjustment.The id band is a key component of the strut that prevents acute adjustment.Adjustments under tension must be made with the id band in place.All acute bands must be replaced with the definitive id band before the patient leaves the operating room.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.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.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.

• Brand Name: SMART FX STRUT MEDIUM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 22472977
• Report Number: 1020279-2025-01220
• Device Sequence Number: 14489629
• Product Code: KTT
• UDI-Device Identifier: 00885556745632
• UDI-Public: 885556745632
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K210953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: 71075720
• Device Lot Number: 24ESM0715
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown