MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5MM PM-P TIBIA T-PL 13H R 170MM; PLATE, FIXATION, BONE

Model Number 72463413

Device Problem Device Damaged by Another Device (2915)

Patient Problem Perforation (2001)

Event Date 02/20/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference:(b)(4).

Event Description

It was reported that, during an internal fixation surgery, when a 3.5 cortical screw was placed on power in the top row of the evos 3.5mm pm-p tibia t-pl 13h r 170mm, the screw head drove straight through the plate and went into the patient's bone.The star tab was destroyed and the plate was deemed unusable due to loss of fixation.It is unknown if this incident caused a surgical delay.The device was removed and a direct lateral 13 hole right was used instead.Current health status of patient is unknown.

Manufacturer Narrative

The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.It is unknown if the instructions for use for the evos plating system was adhered to.This document does warn; ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.¿ the impact to the patient beyond that which has already been reported in the complaint cannot be confirmed nor concluded.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 ifu for evos¿ plating system revealed in the adverse effects section that bending, cracking or fracture of implant components can occur.Besides, the warnings section revealed that it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Also, the important information section revealed that only components made from the same material shall be used together; dissimilar metals shall not be mixed at any time and components from different manufacturers shall only be mixed when advised by the manufacturer.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 surgical technique used or user/procedural variance.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 3.5MM PM-P TIBIA T-PL 13H R 170MM
• Type of Device: 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: 16569347
• MDR Text Key: 311556871
• Report Number: 1020279-2023-00579
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00885556640623
• UDI-Public: 00885556640623
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72463413
• Device Catalogue Number: 72463413
• Device Lot Number: 20MM02298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention