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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 427
Break 156
Fracture 47
Material fragmentation 41
No Known Device Problem 14
Device operates differently than expected 12
Corrosion 10
Unknown (for use when the device problem is not known) 9
Component missing 9
Malfunction 9
Fitting problem 8
No code available 7
Device, or device fragments remain in patient 7
Difficult to remove 6
Material deformation 6
Detachment of device or device component 6
Other (for use when an appropriate device code cannot be identified) 5
No Information 5
Mechanical jam 5
Sticking 4
Device, removal of (non-implant) 4
Detachment of device component 4
Bent 4
Metal shedding debris 3
Use of Device Issue 2
Connection issue 2
Failure to Adhere or Bond 2
Improper or incorrect procedure or method 2
Device clogged 2
Naturally worn 2
Packaging issue 1
Inadequate user interface 1
Cut in material 1
Device or device fragments location unknown 1
Component(s), broken 1
Mechanical issue 1
Malposition of device 1
Difficult to insert 1
Loose or intermittent connection 1
Monitor failure 1
Device handling issue 1
Failure to separate 1
Unintended collision 1
Size incorrect for patient 1
Unintended movement 1
Material integrity issue 1
Tip breakage 1
Device inoperable 1
Foreign material 1
Failure to cut 1
Failure to auto stop 1
Total Device Problems 841

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

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

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