MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5MM X 30MM LCK SCR S-T; PLATE, FIXATION, BONE

Catalog Number	72413530
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: 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(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.
Event or Problem Description
It was reported that, after an internal fixation surgery had been performed on an unknown date, the patient experienced a failed plate screw construct.One (1) evos 3.5mm x 30mm lck scr s-t came out of its position.It is unknown how this adverse event was resolved.The current health status of the patient remains unknown.
Additional Manufacturer Narrative
A2: age or date of birth, b2: outcomes attributed to adverse event, b5: describe event or problem, d6: if implanted, give date, and h6: health effect - impact code.
Event or Problem Description
It was reported that after an internal fixation surgery performed on an unknown date, the patient experienced a failed plate¿screw construct.One (1) evos 3.5 mm × 30 mm lck scr s-t became displaced from its position.This adverse event was treated with hardware removal.The patient¿s current health status remains unknown.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the limited documentation provided, the definitive clinical root cause of the reported fracture and the displaced screw in, could not be determined.Although the surgical technique, the patient¿s advanced age and bone quality could not be ruled out as likely contributing factors.According to the report, this adverse event was treated with hardware removal; however, the patient¿s health status is unknown.The impact to the patient beyond the hardware removal could not be determined since the patient¿s health status was not reported.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for plating systems revealed in precautions 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 the device.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.Other factors that could contribute to the reported event include size selected, surgical technique, alignment 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: EVOS 3.5MM X 30MM LCK SCR 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: 23677334
• Report Number: 1020279-2025-01965
• Device Sequence Number: 13362441
• Product Code: HRS
• UDI-Device Identifier: 00885556636961
• UDI-Public: 885556636961
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K162078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2026

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: 72413530
• Device Lot Number: UNKNOWN
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 11/30/2025; 01/09/2026
• Initial Report FDA Received Date: 11/30/2025
• Supplement Report FDA Received Date: 12/05/2025; 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Required Intervention; Other
• Patient Age: 74 YR
• Patient Sex: Male