MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.7/3.5 AL-D TIBIA PL 14H L 186MM; PLATE, FIXATION, BONE

Model Number	72464314N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, four months after an evos 2.7/3.5 al-d tibia pl 14h l 186mm was implanted, the plate broke.A revision surgery was performed to address this adverse event.The condition of the patient is unknown.
Additional Manufacturer Narrative
H10: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The lab analysis concluded that the tibia plate is fractured by the initiation and subsequent propagation of fatigue cracking.The lab analysis concluded that the fatigue cracking eventually propagated to an extent that the remaining cross section could not bear the imposed patient loading, which led to an overload fracture.Fatigue cracking is caused by the plate bearing cyclic stresses in excess of the material endurance limit for an extended period.These excessive cyclic stresses may be caused by any number of conditions, including but not limited to excessive patient activity levels prior to full bone union applications of loads in excess of the material¿s strength, or poor bone quality.No material or manufacturing deviations were observed during this investigation.According to clinical/medical investigation, smith and nephew has not received relevant clinical documentation to perform a through medical investigation nor to determine a definitive root cause of the reported breakage.Although we cannot rule out non-compliance/early ambulation as a likely contributory factor to the reported failure.The impact to the patient beyond that which has already been reported, cannot be confirmed nor concluded.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.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 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 file and instructions for use document 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 contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.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.Internal complaint reference number: (b)(4).

• Brand Name: EVOS 2.7/3.5 AL-D TIBIA PL 14H L 186MM
• 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 road; memphis, TN 38116 ; 5123913905
• MDR Report Key: 11720731
• Report Number: 1020279-2021-03392
• Device Sequence Number: 14225947
• Product Code: HRS
• UDI-Device Identifier: 00885556643136
• UDI-Public: 00885556643136
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2022

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 Model Number: 72464314N
• Device Catalogue Number: 72464314N
• Device Lot Number: 18DM01574
• 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: 03/29/2021
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2018
• 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 Sex: Unknown