MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 4.5MM DIST FEM PL R 17H 342MM; PLATE, FIXATION, BONE

Catalog Number	72574217
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	09/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after an internal fixation surgery the locking screws appeared to started backing out of the locking hole on the evos 4.5mm dist fem pl r 17h 342mm plate.As a consequence of this issue the affected femur started to collapse.It appears a revision surgery has been conducted but this information is yet to be confirmed.There is no further information.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.The clinical/medical investigation concluded that, per complaint details, the locking screws started to back out of an evos distal locking plate three weeks post implantation and as a consequence the affected femur started to collapse.The provided undated x-ray shows multiple screws with one screw proud from the plate.A review of the provided undated fluoroscopic image indicates what appears to be that the locking plate was retained and at least one screw was removed.However, it is unknown if the other screws were removed and/or replaced.There is also an additional unknown plate and screws noted.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.The root cause of the reported backing out of the locking screws from the plate and femur collapse cannot be confirmed.Based on the limited information, the patient impact includes the revision and additional hardware.Future impact of the additional hardware and this revision is unknown.Evos plate batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed plate.A review of the instructions for use documents for plating systems revealed in warnings that the correct selection of device components is extremely important.The appropriate type and size should be selected for the patient.Failure to use the largest possible components or improper positioning may result in loosening, bending, cracking, or fracture of the device or bone or both.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected, insertion technique, procedural/user error and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.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 4.5MM DIST FEM PL R 17H 342MM
• 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: 17977315
• Report Number: 1020279-2023-02002
• Device Sequence Number: 11389178
• Product Code: HRS
• UDI-Device Identifier: 00885556753170
• UDI-Public: 885556753170
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K213126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2023

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 Catalogue Number: 72574217
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Sex: Unknown