MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 9; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 74012419

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 06/20/2020

Event Type  Injury  

Event Description

It was reported that during tka procedure piece broke off during sawing 5 in 1 femur.No delay.The procedure was finished using the same device.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.The clinical/medical team concluded, this case reports that during "tka procedure piece broke off during sawing 5 in 1 femur." per complaint details, the procedure was finished using the same device, with no delay.Additional information has been requested, but to date it has not been provided.It is unknown if the piece broke inside the patient, and if so whether it was recovered, however, no patient injury or other complications were reported.Based on the limited information provided, no further medical assessment is warranted at this time.Should clinically relevant documentation/ information become available, the clinical/medical task may be re-evaluated.A visual inspection confirmed a top piece of the journey dcf ap fem cut blk 9 is broken off.The device shows significant signs of wear/usage.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 have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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 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 9
• 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: 10281471
• MDR Text Key: 199044409
• Report Number: 1020279-2020-03252
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010556714
• UDI-Public: 03596010556714
• 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
• Type of Report: Initial,Followup
• Report Date: 10/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74012419
• Device Catalogue Number: 74012419
• Device Lot Number: 19CM22756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Initial Date Manufacturer Received: 06/20/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 10/15/2020
• Supplement Dates FDA Received: 10/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention