MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY FLEX-EXT SPACER 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74018611
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a tka, the journey flex-ext spacer 11mm broke outside the patient.There was no significant delay and the procedure was finished using a smith & nephew back up.Patient was not harmed.
Additional Manufacturer Narrative
Section d4 and h4 were updated with the new information received.Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is fractured, and the fractured piece was returned, rendering the device inoperable.The device shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing or material abnormalities 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.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.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.We consider this investigation closed.

• Brand Name: JOURNEY FLEX-EXT SPACER 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11886841
• Report Number: 1020279-2021-04683
• Device Sequence Number: 3149361
• Product Code: JWH
• UDI-Device Identifier: 03596010557124
• UDI-Public: 03596010557124
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2021

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 Model Number: 74018611
• Device Catalogue Number: 74018611
• Device Lot Number: 13KM19923
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 05/27/2021; 06/08/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 05/31/2021; 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1