MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM L-D FEM LK PL16H L 342MM; PLATE, FIXATION, BONE

Model Number	71800016
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a trauma surgery was performed two years ago, the 4.5mm l-d fem lk pl16h l 342mm broke without any external force.Patient has undergone revision surgery.The patient is stable.
Additional Manufacturer Narrative
The device was not returned for evaluation.A x-ray photo was provided which shows the broken plate at the distal 3rd of the femur as well as a plate screw backing out which supports the complaint.The clinical/medical investigation concluded that, without comparison of immediate post-implantation and immediate post-revision x-rays we are unable to determine how the fracture was repaired or whether there was adequate fixation in the primary surgery or to confirm if the noted fracture of the femur is the same location as initially treated and therefore a possible non-union.Consequently, the clinical root cause of the reported fracture cannot be definitively determined.Therefore, it cannot be concluded that the reported events were associated with a malperformance of the implant.The impact to the patient was the fracture and the revision.Since the patient¿s condition has been reported as stable, no further clinical/medical assessment is warranted at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for fracture fixation devices revealed in adverse effects that cracking and fracture of the implant components can occur.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 product specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, abnormal loading or motion of the limb.The contribution of the device to the reported incident could be corroborated as the device was broken and it was required a revision surgery.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: 4.5MM L-D FEM LK PL16H L 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: 15747889
• Report Number: 1020279-2022-04720
• Device Sequence Number: 15003423
• Product Code: HRS
• UDI-Device Identifier: 03596010520043
• UDI-Public: 03596010520043
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K092015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71800016
• Device Catalogue Number: 71800016
• Device Lot Number: 20LM01581
• 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: 10/15/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 12/06/2022
• Date Device Manufactured: 11/03/2020
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown