MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.7/3.5 AL-D TIBIA PL 11H L 153MM; PLATE, FIXATION, BONE

Model Number	72464311
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to the construct was too rigid and this lead to the plate failing and fracturing.The fractured plate was replaced with the same plate but with a different screw configuration.No more information will be provided.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to the construct was too rigid and this lead to the plate failing and fracturing.The associated evos anterolateral distal stainless steel plate was not returned for evaluation.Therefore a product analysis could not be performed.As device details were not made available, device history record review cannot be completed.Complaint history review could not be performed with any accuracy due to lack of batch information.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Without the return of the actual product involved and no batch information provided, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.
Additional Manufacturer Narrative
Part number: 72464311n.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to the construct was too rigid and this lead to the plate failing and fracturing.The associated evos anterolateral distal stainless steel plate, used for treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device details were not made available, device history record review cannot be completed.Complaint history for the listed part revealed no prior complaints for the listed failure mode.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.A clinical analysis noted the patient impact beyond the fractured plate and revision surgery could not be determined as no medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Without the return of the actual product involved and no batch information or patient medical records provided, no root cause can be determined.According to the risk management file, possible causes could include but not limited to size of device or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: EVOS 2.7/3.5 AL-D TIBIA PL 11H L 153MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8884377
• Report Number: 1020279-2019-03023
• Device Sequence Number: 14078292
• Product Code: HRS
• UDI-Device Identifier: 00885556641040
• UDI-Public: 00885556641040
• Combination Product (Y/N): N
• PMA/510(K) Number: K170457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/20/2020

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: 72464311
• Device Catalogue Number: 72464311N
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 07/15/2019; 07/15/2019; 01/15/2020
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 11/05/2019; 11/06/2019; 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization