MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 4; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 74012414

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/30/2020

Event Type  Injury  

Event Description

It was reported that, during a tka procedure, the journey dcf ap femoral cutting block sz 4 presented contamination of inside part of block- chemicals remaining around middle part of block.Multiple methods of sterilization were trialed.A back-up device was opened instead without further delay.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device had a residue within it.The device shows signs of extensive use.The biocompatibility assessment was reviewed and concluded that the residue observed on the device was deemed to present low and acceptable biological risk to patients.The clinical/medical evaluation concluded that based on the documentation provided, the root cause of the reported event could not be definitively concluded; however, the use of automatic pre-wash cycle and final rinsing without deionized water, the auto-wash loading technique, or verifying cleaning technique could not be ruled out as potential contributing factors to the reported events.See ¿s&n ortho devices 01004 v2 01/2015: devices with challenging design features¿.The event was not a failure of the device design or cleaning protocols but likely technique within the hospital.Patient impact beyond the reported approximate 30-minute surgical delay while anesthetized and procedure cancellation would not be anticipated as there was no patient injury reported and the devices were outside of the patient.No further medical assessment can be rendered at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed 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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.A potential probable cause could be but is not limited to contamination, or difficulty cleaning.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.

Event Description

It was reported that, during a tka procedure, the ourney dcf ap femoral cutting block sz 3 and 4 presented contamination of inside part of block- chemicals remaining around middle part of block, instruments were outside the patient.Multiple methods of sterilization trialed.6 sets opened- all deemed unsterile.Procedure was cancelled.

• Brand Name: JOURNEY DCF AP FEM CUT BLK 4
• 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: 11057717
• MDR Text Key: 223359459
• Report Number: 1020279-2020-07712
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010556660
• UDI-Public: 03596010556660
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74012414
• Device Catalogue Number: 74012414
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Date Manufacturer Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1