MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIAL IMPL IMPACTOR; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 74018901

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2020

Event Type  malfunction  

Event Description

It was reported that during a routine efip inspection, the journey tibial implant impactor was found to be broken, its tip unscrews.No patient was involved.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 is broken and coming apart from the handle.This device was manufactured in 2013.This device exhibits signs of significant wear/usage.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 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.

• Brand Name: JOURNEY TIBIAL IMPL IMPACTOR
• 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: 10312932
• MDR Text Key: 200019541
• Report Number: 1020279-2020-03442
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010557285
• UDI-Public: 03596010557285
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74018901
• Device Catalogue Number: 74018901
• Device Lot Number: 13FST0010
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1