MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S3-4LM/RL10MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71422253
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set up for an uka surgery, when opening the sealed package and sealed box of the journey uni tibinrt s3-4lm/rl10mm device, the plastic outer packaging looked as if it was not sealed at all.The procedure was resumed, using a s+n back-up device but it is unknown if there was any delay.Since incident occurred before procedure; patient was not yet involved.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Results of investigation: the device was not returned for evaluation.However, the photographs were reviewed, and revealed that the inner packaging is unsealed.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review made by the quality engineering team revealed that the defect as described in the complaint could not be confirmed as a manufacturing defect.It is highly improbable that an open package would go unnoticed through the multiple inspection steps in the packaging process, including label application and shrink wrapping.The root cause of the complaint could not be determined at this time.Moreover, this is a low severity failure since it would be identified during surgical preparation and, therefore, allow for a different insert to be selected and used for the surgery.Based on this information, no additional actions will be taken due to low overall risk of this complaint.Should additional complaints be submitted, this one will be referenced and reviewed for occurrence and overall risk evaluation.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 component should be firstly placed inside the inner pouch and sealed.Then, the inner pouch should be placed inside the outer pouch and sealed.None of the pouches should be left open.Based on the production order review and the quality engineering investigation performed, we cannot confirm a manufacturing issue associated to the alleged product.A factor that could contribute to the observed failure in the pictures is damage from mishandling from the end user.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.
Event or Problem Description
It was reported that during set up for an uka surgery, when opening the sealed package and sealed box of the journey uni tibinrt s3-4lm/rl10mm device, the plastic inner packaging (sterile cover) looked as if it was not sealed at all.The procedure was resumed, using a s+n back-up device but it is unknown if there was any delay.Since incident occurred before procedure; patient was not yet involved.

• Brand Name: JOURNEY UNI TIBINRT S3-4LM/RL10MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 17368051
• Report Number: 1020279-2023-01484
• Device Sequence Number: 7061406
• Product Code: HSX
• UDI-Device Identifier: 03596010582140
• UDI-Public: 03596010582140
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061011
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: 71422253
• Device Catalogue Number: 71422253
• Device Lot Number: 16CM01246
• 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: 06/30/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/24/2023
• Date Device Manufactured: 03/02/2016
• 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
• Patient Sex: Unknown