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

Model Number	72464411
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, after an internal fixation surgery had been performed on (b)(6) 2020, the evos 2.7/3.5 al-d tibia pl 11h r 153mm broke.A revision surgery was conducted on (b)(6) 2021 to explant the plate.It is unknown what the current health status of the patient is.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this case reports that three months following implantation a revision surgery was performed due to breakage.No relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but are not limited to traumatic injury, abnormal loading of limb, excessive forces applied to implant or surgical technique.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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 2.7/3.5 AL-D TIBIA PL 11H R 153MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12017592
• Report Number: 1020279-2021-05212
• Device Sequence Number: 14353591
• Product Code: HRS
• UDI-Device Identifier: 00885556641095
• UDI-Public: 00885556641095
• Combination Product (Y/N): N
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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: 72464411
• Device Catalogue Number: 72464411
• Device Lot Number: 18HM22910
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 08/30/2021
• 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; Other; Required Intervention