MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE RT SZ 1-2 9MM; 00885556422748

Model Number	74025611
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during tka surgery, upon opening implant box, the journey ii cr insert xlpe right size 1-2 9mm fell from the box because the sterile wrap was undone.An equivalent implant was available to be used.Surgery was not significantly delayed.The patient outcome is unknown.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device was returned without its packaging.A review of the provided pictures appeared to show the device in its opened original box with the device not sealed in the sterile pouch.The pouch appeared to have a breached seal.The device shows no sign of use.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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documentation revealed this failure mode was previously identified.Some potential probable causes for this event could include improper storage or rough handling.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 CR ISRT XLPE RT SZ 1-2 9MM
• Common Device Name: 00885556422748
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10323924
• Report Number: 1020279-2020-03516
• Device Sequence Number: 11031177
• Product Code: JWH
• UDI-Device Identifier: 00885556422748
• UDI-Public: 00885556422748
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K152726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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 Expiration Date: 10/28/2022
• Device Model Number: 74025611
• Device Catalogue Number: 74025611
• Device Lot Number: 12KM18203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1