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 Unstable (1667)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the poly inserter is not working properly.It has been in service for over 7 years and is too loose, so it is difficult to put 1-2 inserts in with them.Fault in device was noticed after procedure.No surgical delay or injury to the patient was reported.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.Internal complaint reference number: case (b)(4).

• 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: 11093195
• MDR Text Key: 224245862
• Report Number: 1020279-2020-07978
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

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
• Device Operator: Health Professional
• Device Model Number: 74018911
• Device Catalogue Number: 74018911
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 03/30/2021
• Supplement Dates FDA Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1