• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY ART ISRT ASSM TOOL PRSTHSS,KNEE,PTLL/FMRTBL,SM-CNSTRND,UNCMNTD,PRS,CTD,PLYMR/MTL/PLYMR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW, INC. JOURNEY ART ISRT ASSM TOOL PRSTHSS,KNEE,PTLL/FMRTBL,SM-CNSTRND,UNCMNTD,PRS,CTD,PLYMR/MTL/PLYMR Back to Search Results
Model Number 74018911
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/12/2019
Event Type  Malfunction  
Event Description

It was reported that during a tka procedure, when the surgeon went to put the insert in, the gun was not pushing the insert into the tibia. Instead, the tibial impactor was used to get the insert to sit down. There was a delay of 0-30 minutes. No patient injuries were reported.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameJOURNEY ART ISRT ASSM TOOL
Type of DevicePRSTHSS,KNEE,PTLL/FMRTBL,SM-CNSTRND,UNCMNTD,PRS,CTD,PLYMR/MTL/PLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key9578862
MDR Text Key174785013
Report Number1020279-2020-00199
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 04/02/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/10/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number74018911
Device Catalogue Number74018911
Device LOT Number06JM08095
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/30/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-