MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR TIB BASE IMPLANT IMPACTOR; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74014533
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the plastic piece of the instrument broke on the last impaction so backup needed.Nothing left in the patient, no injuries or delays reported.No injuries or delays reported.
Additional Manufacturer Narrative
The associated journey ii xr tibial base implant impactor was returned and evaluated.Visual inspection of the device confirms that the bumper pad has fractured.This failure mode has been previously identified.The device was manufactured in 2015.A design change has been implemented to reduce/eliminate this failure mode from recurrence.This device was manufactured prior to these corrective actions.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JRNY II XR TIB BASE IMPLANT IMPACTOR
• 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: 8479460
• Report Number: 1020279-2019-01360
• Device Sequence Number: 11175321
• Product Code: JWH
• UDI-Device Identifier: 00885556242391
• UDI-Public: 00885556242391
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141471
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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 Catalogue Number: 74014533
• Device Lot Number: 15CGA0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1