MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM PROX FEMUR LCK PLATE 12H R 288MM; PLATE, FIXATION, BONE

Model Number	74820512
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, after an internal fixation surgery, one (1) 4.5mm prox femur lck plate 12h r 288mm implant broke/failed.It is unknown how the reported event was or will be treated.The patient's current health status is unknown.
Additional Manufacturer Narrative
Section h3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, without the requested clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause and/or patient outcome beyond that which was documented in the compliant could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should any additional medical relevant information be provided, this case would be re-assessed.Device 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 device.A review of the instructions for use documents was performed, and the fracture fixation devices reveals in adverse effects that cracking and fracture of the implant components can occur.With repeated stress in patients with delayed healing or nonunion, the appliance will inevitably bend, break or pull out of bone.Also, according to warnings, 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.Additionally, the precautions section reveals that postoperative instructions to patients and appropriate nursing care are critical.Early weight bearing substantially increases implant loading and increases the risk of loosening, bending or breaking the device.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.According with inspection procedure, the material confirmation should be verified with vendor certificate.Also, material specification, states that quality and manufacture of special quality high strength stainless steel forgings shall be controlled; a certification of all material is required and shall include any numerical test results and state that the product conforms to the requirements of the specification.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, surgical technique, postoperative care, patient anatomy, abnormal loading of limb, excessive forces 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.
Additional Manufacturer Narrative
Corrected data: b2 (outcomes updated: revision confirmed), b5 (narrative updated), h6(health effect - impact code).
Event or Problem Description
It was reported that, after an internal fixation surgery, one (1) 4.5mm prox femur lck plate 12h r 288mm implant broke/failed.The patient underwent revision surgery on (b)(6) 2023.The patient's current health status is unknown.

• Brand Name: 4.5MM PROX FEMUR LCK PLATE 12H R 288MM
• 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: 16439809
• Report Number: 1020279-2023-00411
• Device Sequence Number: 3135661
• Product Code: HRS
• UDI-Device Identifier: 03596010624482
• UDI-Public: 03596010624482
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K072818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2023

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 Model Number: 74820512
• Device Catalogue Number: 74820512
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2023
• Supplement Date Received by Manufacturer: 03/01/2023; 03/22/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 03/06/2023; 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Unknown