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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 776
Break 292
Corrosion 191
No code available 139
Material fragmentation 68
Fracture 58
Device operates differently than expected 23
No Information 19
Component missing 18
No Known Device Problem 17
Fitting problem 16
Detachment of device or device component 15
Mechanical jam 12
Malfunction 9
Unknown (for use when the device problem is not known) 9
Device, or device fragments remain in patient 7
Bent 7
Material deformation 7
Difficult to remove 6
Metal shedding debris 6
Other (for use when an appropriate device code cannot be identified) 5
Crack 5
Disassembly 4
Detachment of device component 4
Sticking 4
Device, removal of (non-implant) 4
Connection issue 3
Naturally worn 3
Component falling 3
Device clogged 3
Failure to Adhere or Bond 3
Device Cleaning Issue 2
Loose or intermittent connection 2
Mechanical issue 2
Improper or incorrect procedure or method 2
Use of Device Issue 2
Packaging issue 2
Material twisted 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
Device handling issue 1
Unintended movement 1
Tip breakage 1
Device inoperable 1
Difficult to insert 1
Material separation 1
Size incorrect for patient 1
Monitor failure 1
Unintended collision 1
Unsealed device packaging 1
Difficult to position 1
Foreign material 1
Component(s), broken 1
Total Device Problems 1776

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

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