MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5MM 1/3 TUBULAR PL 8H 94MM; SCREW, FIXATION, BONE

Model Number	72440808
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after an internal fixation surgery performed on (b)(6) 2021, the evos 3.5mm 1/3 tubular pl 8h 94mm broke off at the fracture site.This adverse event led to a revision surgery, which performed date is unknown.The patient current health status is unknown.
Event or Problem Description
It was reported that, after an internal fixation surgery performed on (b)(6) 2021, the evos 3.5mm 1/3 tubular pl 8h 94mm broke off at the fracture site.This adverse event led to a revision surgery performed on (b)(6) 2021 in which the device was explanted.The patient current health status is unknown.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was fractured into two piece, rendering the device inoperative.There was a crack along another section of the device.The screws were returned as well.The clinical/medical evaluation concluded that the undated x-ray photos provided confirms the implant breakage at the fracture site as well as persistent fracture in the fibula.Based on the limited information provided the root cause of the reported breakage could not be determined.The patient impact beyond the reported removal could not be determined.No further clinical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.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 documents revealed this failure mode and potential harm was previously identified.Some potential probable causes for this event could include but not limited to traumatic injury or excessive force applied to the device.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 1/3 TUBULAR PL 8H 94MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12446856
• Report Number: 1020279-2021-06753
• Device Sequence Number: 19644656
• Product Code: HWC
• UDI-Device Identifier: 00885556640043
• UDI-Public: 00885556640043
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K162078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72440808
• Device Catalogue Number: 72440808
• Device Lot Number: 20LT44447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 10/14/2021
• 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; Required Intervention
• Patient Age: 21 YR