MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY FLEX-EXT SPACER 10MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74018610
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the flex spacer is broken.No pieces fell into the surgical site, all pieces accounted for.S&n backup was used.No delay to procedure no injury to patient.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device fractured into two pieces and both pieces were returned.The device was manufactured in 2016 and exhibits signs of moderate wear/usage.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 have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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.

• Brand Name: JOURNEY FLEX-EXT SPACER 10MM
• 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: 8348156
• Report Number: 1020279-2019-00626
• Device Sequence Number: 1833390
• Product Code: JWH
• UDI-Device Identifier: 03596010557117
• UDI-Public: 03596010557117
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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: 74018610
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 02/18/2019
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1