MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 LT 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 74027261

Device Problem Unsealed Device Packaging (1444)

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

Event Date 08/02/2023

Event Type  malfunction  

Event Description

It was reported that, during the set up for a tka surgery, it was noticed on a jrny ii bcs xlpe art isrt sz 5-6 lt 9mm that the outer soft plastic packaging on the box was intact.The peel seal was intact.The plastic was opened and the seal removed, the box was opened.Inside the box, the prothesis outer package and inner package were open.The prosthesis was not sterile and could not be used.The procedure was performed, after a non-significant delay, with a s+n back-up device.Since incident occurred before procedure; patient was not yet involved.

Manufacturer Narrative

Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

Manufacturer Narrative

H6: the packaging was not returned for evaluation; therefore, a packaging analysis could not be performed.A review made by the quality engineering team concluded that it would be highly unlikely that the inner packaging tray lids would be completely unsealed and then labels applied and then boxed.Both packagers seems to indicate this would be immediately noticeable when either doing the inspection or applying labels.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 component should be placed in a poly bag and then inside an inner tray that should be sealed, to eventually be placed in an outer tray that should be sealed.At this time, we have no evidence to suspect 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 or mishandling.Based on this investigation, the need for corrective action is not indicated.Should the packaging 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.

Manufacturer Narrative

The associated device packaging was returned and evaluated.The visual inspection revealed that the box, sterile packaging and the plastic bag the device is in, are all open.A review made by the quality engineering team revealed that it would be highly unlikely that the inner packaging tray lids would be completely unsealed and then labels applied and then boxed.Both packagers indicated this would be immediately noticeable when either doing the seal operation, seal inspection, applying inner or outer labels, and placed into an outer carton.At this time, this complaint appears isolated from other packaging complaints due to its visually obvious nature and the fact that it appears to be properly sealed at some point and later opened (intentionally or inadvertently).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 component should be placed in a poly bag and then inside an inner tray that should be sealed, to eventually be placed in an outer tray that should be sealed.At this time, we have no reason to suspect that the package failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include damage during shipping and/or mishandling.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.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 5-6 LT 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: 17599083
• MDR Text Key: 321690469
• Report Number: 1020279-2023-01643
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556177969
• UDI-Public: 00885556177969
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K111711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 74027261
• Device Lot Number: 23BM13693
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2023
• 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