MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE RT SZ 7-8 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74025671
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a tka surgery.When opening a box fully sealed with plastic, the inside wrapping was opened and the jrny ii cr isrt xlpe rt sz 7-8 9mm slid out of both packaging bags.The procedure was successfully completed without delay using a smith and nephew back up device.Patient was not harmed.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: ¿the associated device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.There are no indications that the part was not packaged according to specification.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include improper storage, rough handling or shipping damage.This issue was previously evaluated by our packaging development team and they determined the low complaint rate did not warrant a design change at this time.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.¿.

• Brand Name: JRNY II CR ISRT XLPE RT SZ 7-8 9MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11816891
• Report Number: 1020279-2021-04158
• Device Sequence Number: 3149125
• Product Code: JWH
• UDI-Device Identifier: 00885556422328
• UDI-Public: 00885556422328
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2021

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 Model Number: 74025671
• Device Catalogue Number: 74025671
• Device Lot Number: 17DM10875
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 09/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1