MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIAL IMPL IMPACTOR; PROST, KNEE, PAT/FEMTIB, SEMI-CONSTRAIN, UNCEMENT, POROUS, COAT, POLY/MET/POLY

Catalog Number 74018901

Device Problems Break (1069); Naturally Worn (2988)

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

Event Date 06/08/2020

Event Type  malfunction  

Event Description

It was reported that during the setup for a tka procedure, it was found that the edges of the journey tibial implant impactor were worn and jagged, even pieces have flaked off.There was an s+n backup device available to continue the procedure without delays.No other complications were reported.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned impactor confirms the bumper has multiple scratches, burrs and deep gouges in the plastic.There are also signs of pieces of the bumper flaking off.This device was manufactured in 2018.This device exhibits signs of significant wear/usage.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 any manufacturing or material abnormalities that could have caused or contributed to the reported incident.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 TIBIAL IMPL IMPACTOR
• Type of Device: PROST, KNEE, PAT/FEMTIB, SEMI-CONSTRAIN, UNCEMENT, POROUS, COAT, POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10213786
• MDR Text Key: 197082355
• Report Number: 1020279-2020-02845
• Device Sequence Number: 1
• Product Code: MBH
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 74018901
• Device Lot Number: 18KSM0461
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1