MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 6; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Model Number 74012416

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/22/2019

Event Type  Injury  

Event Description

It was reported that during surgery, while removing the block, it came apart leaving the peg/slide stuck inside the bone.No delay reported.No s&n backup device was available.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that this complaint reports a journey ii cutting block broke apart and a piece stuck in the patient¿s bone and could not be removed.The retained piece is made of the 17.4 stainless steel, which is not an implantable material.No clinical/medical documentation or x-rays have been submitted to support this complaint.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.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 have no 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.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.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: JOURNEY DCF AP FEM CUT BLK 6
• Type of Device: PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9313377
• MDR Text Key: 166746202
• Report Number: 1020279-2019-03983
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010556684
• UDI-Public: 03596010556684
• 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: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74012416
• Device Catalogue Number: 74012416
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention