MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II TKA FEM SIZING GDE RT; PRSTHESIS,KNEE, PATLLOFEMRTIBIL,SMI-CNSTRIND,CMNTD,PLYMR/MTL/PLYMR

Model Number	74012456
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a total knee arthroplasty the surgeon complained that this sizing guide is too loose.Smith and nephew backup device available but was not necessary.There was a delay of 1 to 2 minutes.No harm to the patient reported.No adverse affects of any kind happened.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device was manufactured in 2013 and shows signs of extensive use.A functional evaluation of the returned device confirms the stated failure mode.The adjustment knob on the device is loose, rendering the device inoperable.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.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: JRNY II TKA FEM SIZING GDE RT
• Common Device Name: PRSTHESIS,KNEE, PATLLOFEMRTIBIL,SMI-CNSTRIND,CMNTD,PLYMR/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10719063
• Report Number: 1020279-2020-05638
• Device Sequence Number: 17025733
• Product Code: JWH
• UDI-Device Identifier: 03596010672049
• UDI-Public: 03596010672049
• 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): 01/19/2021

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: 74012456
• Device Catalogue Number: 74012456
• Device Lot Number: 13FBQ0002
• Initial Date Received by Manufacturer: 09/27/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1