MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II ISRT XLPE DD RT SZ 7-8 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 74025771

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 03/13/2024

Event Type  malfunction  

Event Description

It was reported that, during a tka surgery, the sterile package of a jrny ii isrt xlpe dd rt sz 7-8 9mm was opened in the sealed box.The procedure was resumed, without any delay, using a s+n back-up device.No injury was reported as a consequence of this issue.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H10: after further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that the sterile package of a jrny ii isrt xlpe dd rt sz 7-8 9mm was opened in the sealed box.However, after the visual inspection of the device, it was determined that the issue does not meet the criteria to be reportable, since it was revealed that the outer packaging of the product was broken but the inner packaging was in tact, therefore, the sterile barrier was not breached and the implant was still sterile.Moreover, if the device malfunction were to recur, it would not be likely to cause or contribute to a death or serious injury.H3, h6: the associated product was returned and evaluated.The visual inspection revealed that the outer packaging of the product was broken.The inner packaging was intact.However, a review made by the quality engineering team revealed that, based on the photographs provided and the holes being on the side of the pouches, the defect occurred in distribution and would not be related to a manufacturing issue.The location where the pouches were ruptured is not the location where they are heat sealed in production.Visual inspections performed during production are set-up to detect any issues not only with the device but also with the sterile barrier system.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.However, we will continue to monitor for future complaints and investigate as necessary.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 revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.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 with the packaging sequence, before the sterilization process, the component should be placed inside the inner pouch before sealing it.Then, the inner pouch should be placed into the outer pouch and, finally, the outer pouch should be sealed.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include damage during shipping, mishandling and/or storage.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.Corrected data: h6 (medical device problem code).

• Brand Name: JRNY II ISRT XLPE DD RT SZ 7-8 9MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 19034350
• MDR Text Key: 339269480
• Report Number: 1020279-2024-00672
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556098813
• UDI-Public: 00885556098813
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113482
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/13/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 74025771
• Device Lot Number: 20FM15553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1