MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 3; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 74012413

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2020

Event Type  Injury  

Event Description

It was reported that, during surgery, the journey dcf ap fem cut blk 3 broke while instrument was inside of patient.Procedure was finished with same device.No surgical delay reported.

Manufacturer Narrative

The device, used in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is broken and has signs of wear and tear from use.The device was manufactured in 2019.Per complaint details, the device broke during; however, no pieces fell into the patient/operative site and the procedure was successfully completed without delay using the same device.Based on the information provided, although the device broke during use, there was no retained foreign body, no patient harm, and no delay reported.The product evaluation did confirm the failure mode and noted signs of wear and tear of the device.Since no injury/harm or delay was alleged, no further patient impact would be anticipated and no further medical assessment is warranted at this time.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history for the listed part revealed no prior complaints.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 re-usable instruments be routinely inspected for wear/damage and replaced as necessary.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.Credit will be issued for the device.

• Brand Name: JOURNEY DCF AP FEM CUT BLK 3
• 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: 10698116
• MDR Text Key: 211918045
• Report Number: 1020279-2020-05511
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010556653
• UDI-Public: 03596010556653
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74012413
• Device Catalogue Number: 74012413
• Device Lot Number: 19HM07492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention