MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY ART ISRT ASSM TOOL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 74018911

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2020

Event Type  malfunction  

Event Description

It was reported that, during inspection or set up, the piece in the handle that allows the handle to squeeze has broken off and needs to be replaced.Nothing fell into patient.The procedure was finished using a smith and nephew back up device.No delay to procedure, no harm to patient.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection confirms one of the spring leaf is broken off the device.The broken piece was not returned with the device.The device was manufactured in 2011.The device exhibits signs of significant wear/ usage.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 a manufacturing abnormality that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: JOURNEY ART ISRT ASSM TOOL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10477145
• MDR Text Key: 205121464
• Report Number: 1020279-2020-04331
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010557292
• UDI-Public: 03596010557292
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74018911
• Device Catalogue Number: 74018911
• Device Lot Number: 11JM02562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1