• 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. SCREWDRIVER RELEASE HANDLE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

  • 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. SCREWDRIVER RELEASE HANDLE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71674084
Device Problem Material Twisted/Bent (2981)
Patient Problem No Patient Involvement (2645)
Event Date 07/22/2020
Event Type  malfunction  
Event Description
It was reported that the tip of the release handle was bent and needs replacement. No patient involved in the case. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSCREWDRIVER RELEASE HANDLE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks rd.
memphis, TN 38116
0447940038
MDR Report Key10405307
MDR Text Key202854470
Report Number1020279-2020-03916
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71674084
Device Catalogue Number71674084
Device Lot Number09EM03956
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/06/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-