MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR INS XLPE LAT 5-6 RT 11MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74023853
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during operation when inserting xr insert, the insert cannot be inserted and locked accordingly.Finally, the locking mechanism had been broken.So the back-up device was opened and tried to insert, but the insert also cannot be inserted and broke again.After that, the back-up device) was opened and inserted, and it has been fit well and completed the surgery.This caused 50 minuted delay of the surgery time.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, reportedly during the operation the xr insert (74023853/16fm13167) broke and could not be inserted and locked accordingly.A back-up device (74023854/16fm13168) was opened, but it also broke during the locking process.A second back-up device had to be opened and inserted to complete the surgery.This caused a 50 minute delay of the surgery time.Although there was a 50 minute delay no patient harm is being reported.Since no harm to the patient is being reported and a back up device was available no further medical assessment is warranted.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: JRNY II XR INS XLPE LAT 5-6 RT 11MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8305981
• Report Number: 1020279-2019-00395
• Device Sequence Number: 154835
• Product Code: JWH
• UDI-Device Identifier: 00885556615720
• UDI-Public: 00885556615720
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

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: 06/14/2026
• Device Catalogue Number: 74023853
• Device Lot Number: 16FM13167
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1