MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 5; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 74012415

Device Problems Connection Problem (2900); Material Deformation (2976)

Patient Problems Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/30/2021

Event Type  Injury  

Event Description

It was reported that, during a tka surgery while the instrument was inside of the patient a journey dcf ap fem cut blk 5 mechanism to lock the block was stripped and failed.When the block was placed onto the femur, the knob began to move.The surgeon had to hold the block in place while cutting to prevent his slots from moving.Even with that, the block still moved during the cuts.The cut shift was 1-2mm.The procedure was successfully completed with no significant delay and using the same device.Patient was not harmed.

Manufacturer Narrative

H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned cutting block confirms burrs and gouges in the cutting slots of the device.This device exhibits signs of significant wear/usage.A functional evaluation confirms the locking mechanism will not lock in place due to the screw inside is stripped.The clinical/medical evaluation concluded that per correspondence, the mechanism to lock the block was stripped and failed prior to the procedure/during setup and a backup was not available.It was communicated that no further unplanned interventions were required due to the reported event; however, the surgeon ¿ had to hold the block in place while cutting¿.The block still moved¿ resulting in a ¿cut shift was 1-2mm¿.Reportedly, the procedure was successfully completed within a 0-30 minute surgical delay, using the same device, without patient harm and ¿was not having any issues¿.Responses regarding the post-mimb inquiries of 'angular versus height cut" had not been received as of the date of this medical investigation sign-off (b)(6) 2021.A complaint history review found related failures; this failure mode will be monitored for future complaints 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.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 repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.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.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JOURNEY DCF AP FEM CUT BLK 5
• 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: 11846700
• MDR Text Key: 251361415
• Report Number: 1020279-2021-04410
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010556677
• UDI-Public: 03596010556677
• 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: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74012415
• Device Catalogue Number: 74012415
• Device Lot Number: 17AM17207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention