MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 5; PROST, KNEE, PATEL/FEM, SEMI-CONS, UNCEM, PORO, COAT, POLY/METAL/POLY

Model Number 74012415

Device Problem Connection Problem (2900)

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

Event Date 04/01/2020

Event Type  malfunction  

Event Description

It was reported that during the tka procedure the slap hammer won't slide over the middle portion of the device.The slap hammer was unable to take the cutting block off so the block was taken off by hand.No delay.No backup was available.No injury reported.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device was manufactured in 2008 and shows signs of extensive wear/usage.A functional evaluation could not confirm the stated failure mode.The device functions as intended with a mating slap hammer.A review of complaint history did not reveal additional complaints for the listed batch.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 do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.Should additional information be received, the complaint will be reopened.No further investigation is 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 5
• Type of Device: PROST, KNEE, PATEL/FEM, SEMI-CONS, UNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9991328
• MDR Text Key: 188693891
• Report Number: 1020279-2020-01363
• Device Sequence Number: 1
• Product Code: MBH
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74012415
• Device Catalogue Number: 74012415
• Device Lot Number: 08KM18239
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 05/26/2020
• Supplement Dates FDA Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1