MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II TKA FEM SIZING GDE RT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74012456
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, surgeon noticed that the screw was stripped.No delay, no backup.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the returned journey ii tka femoral sizing guide indicated body is worn with small nicks and scratches.This device was manufactured in 2013, showing signs of wear/use.A functional evaluation indicated that the paddle feet do not stay in position when the degrees are selected, confirming the stated complaint.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 have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that there was no confirmation of a change in the original procedure due to a backup, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: JRNY II TKA FEM SIZING GDE RT
• 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: 8310696
• Report Number: 1020279-2019-00467
• Device Sequence Number: 206006
• Product Code: JWH
• UDI-Device Identifier: 03596010672049
• UDI-Public: 03596010672049
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2019

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: 74012456
• Device Lot Number: 13CBG0028
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 01/14/2019; 01/14/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 03/01/2019; 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1