MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5MM CVD PROX HUM PL 12H R 180MM; PLATE, FIXATION, BONE

Model Number	72467212
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, after an internal fixation surgery (unknown date), on (b)(6) 2021 it was noticed on an x-ray, that the evos 3.5mm curved proximal humerus plate 12 hole right 180mm broke.A revision surgery was performed to extract the device (date unknown).The current health status of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The manufacturing process of the device did not contribute to the reported event.A visual inspection of the returned device confirmed the stated failure mode.The device was fractured into multiple pieces.The fractured component was not returned.A review of complaint history did not reveal similar events for the listed device.The clinical/medical evaluation concluded that a single x-ray photo dated 9-27-2021, was provided that revealed the evos 3.5mm curved proximal humerus plate 12 hole right 180mm was broken post-operatively, however, the implantation date is unknown.Subsequently, smith and nephew has not received adequate clinical documentation to fully evaluate the complaint.Therefore, the root cause and/or patient outcome beyond that which was documented in the case could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should any additional relevant clinical information be provided, this case would be re-assessed.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.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.

• Brand Name: EVOS 3.5MM CVD PROX HUM PL 12H R 180MM
• 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: 12836542
• Report Number: 1020279-2021-08251
• Device Sequence Number: 20028726
• Product Code: HRS
• UDI-Device Identifier: 00885556665480
• UDI-Public: 00885556665480
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K173293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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: 72467212
• Device Catalogue Number: 72467212
• Device Lot Number: 19MM14295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2019
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown