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	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the case the device got broken.No pieces were left in the patient.The procedure was successfully completed without delay using an s&n back-up device.
Additional Manufacturer Narrative
The device, intended for use in treatment, was not returned for evaluation, the reported event could not be confirmed.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 products failed to meet any product specifications at the time of manufacture.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• 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 road; memphis TN 38116
• MDR Report Key: 9451293
• Report Number: 1020279-2019-04383
• Device Sequence Number: 16752055
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2020

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: No Information
• Device Model Number: 74012456
• Device Catalogue Number: 74012456
• Device Lot Number: 13FBG0001
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 03/05/2020
• Patient Sequence Number: 1