MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5MM P/A P-D TIBIA PL 3H R 63MM; PLATE, FIXATION, BONE

Catalog Number 72454603

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2020

Event Type  Injury  

Event Description

It was reported that during surgery, when surgeon tried to screw the plate on to the bone the screw broke through the petals on the plate and went right through the plate, so it did not hold the plate on.The plate petals were all damaged in the screw hole.The plate was removed and another plate was opened.Procedure was concluded with a backup device from smith and nephew.No injury and a delay of less than 30 minutes was reported.

Event Description

It was reported that during surgery, when surgeon tried to screw the plate on to the bone the screw broke through the petals on the plate and went right through the plate, so it did not hold the plate on.The plate petals were all damaged in the screw hole and a washout was performed to continue with surgery.Screws and plate were removed and procedure concluded with a backup device from smith and nephew.No injury, no additional holes and a delay of less than 30 minutes was reported.

Manufacturer Narrative

Results of investigation: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.One of the screw holes is damaged.The tabs are bent, rendering the device inoperable.The device was manufactured in 2019 and shows signs of attempted use.A dimensional evaluation of the returned device could not confirm the stated failure mode.The device was found to be within tolerance.A review of complaint history did not reveal similar events for the listed device.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.The manufacturing process of the device did not contribute to the reported event.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 surgical technique used, size of device or user/procedural variance (not to say user error).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.We consider this investigation closed.

• Brand Name: EVOS 3.5MM P/A P-D TIBIA PL 3H R 63MM
• 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: sarah freestone ; 1450 brooks rd.; memphis, TN 38116 ; 0447940038
• MDR Report Key: 10163623
• MDR Text Key: 195432555
• Report Number: 1020279-2020-02449
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K170457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72454603
• Device Lot Number: 19JM09131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention