MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY ART ISRT ASSM TOOL; PROSTHSIS,KNEE,PATLLO/FMORTIBIL,SMICONSTRAIND,UNCMNTD,POROUS,COATD,POLYMR/MTAL

Model Number 74018911

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 08/06/2020

Event Type  malfunction  

Event Description

It was reported that the poly inserter broke.It occured while using the instrument.There was no surgical delay.The procedure was finished with an smith and nephew backup device.No death or injury was reported.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection confirmed the spring is broken on the journey art isrt assm tool.The device shows significant signs of wear/usage.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 have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: JOURNEY ART ISRT ASSM TOOL
• Type of Device: PROSTHSIS,KNEE,PATLLO/FMORTIBIL,SMICONSTRAIND,UNCMNTD,POROUS,COATD,POLYMR/MTAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10460423
• MDR Text Key: 204568251
• Report Number: 1020279-2020-04248
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010557292
• UDI-Public: 03596010557292
• 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: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74018911
• Device Catalogue Number: 74018911
• Device Lot Number: 13FPG0051
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention