MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 4; PROSTHSIS, KNEE, FMOROTIBIAL, SMI-CONSTRAIND, CMNTD, MTAL/POLYMR

Catalog Number 74012414

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2019

Event Type  malfunction  

Event Description

It was reported that the set screw, spring, and rod fell out of bottom of cut block while cutting femur, necessitating an intra-op x-ray to confirm all parts had been removed from joint.Delay of 15 min.No replacement device available cuts were completed correctly.Cut block available for return.

Manufacturer Narrative

The associated complaint device was returned and evaluated.A visual inspection of the returned cutting blocks confirms set screw, spring, and rod came loose from the device.These items were not returned with the device.There are also burrs and gouges in the metal.The device was manufactured in 2014.A functional evaluation was conducted and confirms the cutting block knob is seized in place.It will not turn as intended.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: JOURNEY DCF AP FEM CUT BLK 4
• Type of Device: PROSTHSIS, KNEE, FMOROTIBIAL, SMI-CONSTRAIND, CMNTD, MTAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9348913
• MDR Text Key: 167208686
• Report Number: 1020279-2019-04086
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 74012414
• Device Lot Number: 14GM00060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2019
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1