MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5MM L-P TIBIA PL 8H L 113MM; PLATE, FIXATION, BONE

Model Number 72463108

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, the seal of the transparent packaging of an evos 3.5mm l-p tibia pl 8h l 113mm was not sealed, therefore was not sterile.The cardboard, on the other hand, was perfect and so was the plastic that covers the cardboard box.This was noticed upon set-up or inspection for an internal fixation surgery.The patient was not involved at that moment.

Manufacturer Narrative

The associated device was returned and evaluated.The visual inspection revealed device's packaging was found to be unsealed, rendering the device unsterile and inoperative.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 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 to the packaging sequence, the nylon pouch should be sealed with the blue polyurethane pouch and plate inside.A review made by the quality engineering team revealed that no other complaints were returned for the associated production lot.Quality hold was not pursued, as due to the manual nature of the packaging process, there is no evidence that other product within the lot was affected.Additionally, packaged part inspection was required 100% per form.Due to the anticipated risk within the risk management files, lack of additional complaints, and overall low risk, no additional action will be taken at this time.If additional complaints are received for this lot, an investigation will be re-opened for additional investigation and containment consideration.At this time, we do have reason to suspect that the product failed to meet product specifications at the time of manufacture.The root cause of this event was determined to be an error during the manual packaging process.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 for future complaints and investigate as necessary.We consider this investigation closed.Internal complaint reference number: (b)(4).

• Brand Name: EVOS 3.5MM L-P TIBIA PL 8H L 113MM
• 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: 15655127
• MDR Text Key: 303437693
• Report Number: 1020279-2022-04507
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00885556640418
• UDI-Public: 00885556640418
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K170457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72463108
• Device Catalogue Number: 72463108
• Device Lot Number: 20HM05163A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2020
• 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