MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5MM COND M-D FEM PL R 115MM 5H; PLATE, FIXATION, BONE

Catalog Number	72573202
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	07/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after internal fixation surgery was performed on an unknown date, it was identified that an evos 3.5mm condylar medial distal femur plate r 115mm 5h was not effective in maintaining reduction.It is unknown how this event was treated.Patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6.The associated device was returned and evaluated.A visual inspection of the returned device does not reveal any defects.A dimensional evaluation reveals the parts were inspected per the approved inspection procedure against the released drawing print and all features were found to be in specification per the print.The cause of the failure could not be linked to the manufacturing of the product so no non-conformance or quality hold is required at this time.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.The clinical/medical evaluation concluded that per complaint details, the evos 3.5mm condylar medial distal femur plate r 115mm 5h was not effective in maintain reduction.As of the date of this medical investigation, the requested clinical documentation has not been provided for evaluation.Therefore, there were no clinical factors found which would have contributed to the reported event.The patient impact beyond that which already has been reported could not be determined.No further clinical assessment can be rendered at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A review of the instructions for use for evos¿ plating system revealed in warnings that it is the health care professional¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Also, it is extremely important to select the appropriate size and type components.Failure to use the largest possible components or improper positioning may result in loosening of the device or bone or both.Besides, 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 of the device.Surgical technique information is available on request.Factors that could contribute to the reported event include procedural/user error, surgical complication or patient medical history.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 future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: EVOS 3.5MM COND M-D FEM PL R 115MM 5H
• 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: 17495465
• Report Number: 1020279-2023-01576
• Device Sequence Number: 7821568
• Product Code: HRS
• UDI-Device Identifier: 00885556753026
• UDI-Public: 885556753026
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K201918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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: 72573202
• Device Lot Number: 21AM05406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• 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