MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5MM L-D FIBULA PL 11H L 147MM; PLATE, FIXATION, BONE

Catalog Number	72464911N
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after an internal fixation surgery had been performed on (b)(6) 2024, the patient experienced fracture in the evos 3.5mm l-d fibula pl 11h l 147mm on (b)(6)2024.It was mentioned that the patient had no load bearing until around (b)(6) 2024, and was wearing a protective boot.To address this adverse event, a revision surgery was scheduled for (b)(6) 2024.The patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.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 evos¿ plating system reveals in the 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.Early load bearing should only be considered where there are stable fractures with good bone-to-bone contact.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 the inspection drawing, the final inspection includes the verification of part configuration per print.Also, per material specification, the quality and manufacture of wrought special quality stainless steel alloy bar and other stock forms 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 traumatic 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 L-D FIBULA PL 11H L 147MM
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19918003
• Report Number: 1020279-2024-01512
• Device Sequence Number: 20856765
• Product Code: HRS
• UDI-Device Identifier: 00885556645178
• UDI-Public: 00885556645178
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K170457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 09/05/2024

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: 72464911N
• Device Lot Number: 21HM15224
• 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: 07/16/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown