MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VLP TI 2.4MM X 15MM LCK SCR T7 S-T; PLATE, FIXATION, BONE

Catalog Number	74412415
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Insufficient Information (4580); Loss of fracture reduction (4901)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a primary trauma surgery had been performed on (b)(6) 2025, to treat a distal radius fracture using evos plate and screws, the patient experienced floating/loosening of the evos volar plate 4h left std ti 56mm.On (b)(6) 2026, an x-ray revealed a screw back out.This adverse event was solved by revision trauma surgery on (b)(6) 2026, in which the complaint devices were confirmed; the most proximal locking screw had been passed the screw hole on the plate.Both devices were explanted.Patient's current health status is unknown.No further complications were reported.
Additional Manufacturer Narrative
Internal complain reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates to known inherent 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 confirm a relationship between the reported event and the device or 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.
Additional Manufacturer Narrative
The associated devices were returned and evaluated.A visual inspection of the returned devices concluded the devices present with discoloration from use, some scratching and scuffing, possibly from extraction activities.The devices have no other evident deficiencies which could explain the migration.The clinical/medical investigation concluded that, undated x-ray images were provided for review and confirm the reported; there is displacement of the radius fracture and appears persistent fracture location which may indicate force may have resulted in the pulling through of the screw to the plate however, we cannot conclude a root cause for the reported event.We are unable to rule out sufficient bone quality, adequate fixation, and early mechanical stress as contributing factors.There is no evidence to support that there was a device malfunction.The instructions for use document related to evos plating system does note that postoperative instructions to patients and appropriate nursing care are critical.Early load bearing substantially increases implant loading and increases the risk of loosening, bending or breaking of the device.The patient impact is determined to be the revision procedure, and a brief post-operative recovery phase would be anticipated.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers 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 evos¿ plating system, also revealed that revealed that improper fixation, and/or migration of the components could cause possible adverse effects.A review of the risk management files 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 products and event.At this time, we have no evidence to conclude that the products 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: VLP TI 2.4MM X 15MM LCK SCR T7 S-T
• Common Device Name: PLATE, FIXATION, BONE
• 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: 24310439
• Report Number: 1020279-2026-00194
• Device Sequence Number: 4942183
• Product Code: HRS
• UDI-Device Identifier: 00885556348598
• UDI-Public: 885556348598
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 03/21/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 74412415
• Device Lot Number: 22EM02568
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2022
• 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: PN: 71158104 / LOT: 22MT70375
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male