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

TPLC - Total Product Life Cycle

  • 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
 

New Search Back To Search Results
Device reamer
Regulation Description Orthopedic manual surgical instrument.
Product CodeHTO
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ONYX MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 3
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Dull 868
Break 364
Corrosion 264
No code available 173
Material fragmentation 83
Fracture 60
Device operates differently than expected 24
No Known Device Problem 21
No Information 20
Component missing 20
Detachment of device or device component 19
Fitting problem 17
Material discolored 16
Mechanical jam 14
Bent 12
Crack 9
Unknown (for use when the device problem is not known) 9
Material deformation 9
Malfunction 9
Device, or device fragments remain in patient 7
Disassembly 7
Failure to Adhere or Bond 7
Difficult to remove 6
Metal shedding debris 6
Other (for use when an appropriate device code cannot be identified) 5
Sticking 4
Component falling 4
Device, removal of (non-implant) 4
Connection issue 4
Naturally worn 3
Device clogged 3
Mechanical issue 3
Improper or incorrect procedure or method 2
Use of Device Issue 2
Detachment of device component 2
Device Cleaning Issue 2
Difficult to insert 2
Loose or intermittent connection 2
Material twisted 2
Packaging issue 2
Material Distortion 2
Foreign material present in device 2
Failure to separate 2
Failure to cut 1
Device or device fragments location unknown 1
Malposition of device 1
Cut in material 1
Failure to align 1
Inadequate user interface 1
Material integrity issue 1
Difficult to advance 1
Failure to auto stop 1
Scratched material 1
Unintended movement 1
Device handling issue 1
Foreign material 1
Loss of or failure to bond 1
Component(s), broken 1
Tip breakage 1
Device inoperable 1
Monitor failure 1
Unintended collision 1
Unsealed device packaging 1
Material separation 1
Size incorrect for patient 1
Total Device Problems 2118

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 1 1 1 1 4 2 1 3 5 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II May-26-2016
2 Biomet, Inc. II Oct-06-2014
3 Biomet, Inc. II Dec-04-2012
4 Biomet, Inc. II Mar-04-2011
5 DePuy Mitek, Inc., a Johnson & Johnson Co. II Dec-17-2012
6 DePuy Orthopaedics, Inc. II Mar-20-2013
7 Extremity Medical LLC II Nov-26-2012
8 Sterilmed Inc II Jan-13-2009
9 Stryker Howmedica Osteonics Corp. II May-17-2012
10 Stryker Howmedica Osteonics Corp. II Feb-17-2010
11 Stryker Howmedica Osteonics Corp. II Aug-27-2008
12 Synthes (USA) Products LLC II Nov-23-2016
13 Synthes (USA) Products LLC II Nov-19-2016
14 Synthes (USA) Products LLC II Jun-06-2016
15 Synthes (USA) Products LLC II Jan-05-2016
16 Synthes (USA) Products LLC II Aug-10-2015
17 Synthes USA HQ, Inc. II Aug-12-2013
18 Synthes, Inc. II Jul-16-2015
19 Trilliant Surgical Ltd. II Aug-24-2015

-
-