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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device impactor
Regulation Description Orthopedic manual surgical instrument.
Product CodeHWA
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 946
Fracture 141
No code available 48
Crack 42
Material fragmentation 19
Disassembly 17
Component missing 15
Mechanical jam 14
Malfunction 13
Difficult to remove 12
Device, or device fragments remain in patient 11
Device, removal of (non-implant) 11
Device operates differently than expected 11
Failure to disconnect 10
Sticking 9
Loose or intermittent connection 8
No Information 8
Fitting problem 7
Unknown (for use when the device problem is not known) 6
Mechanical issue 6
Bent 6
Naturally worn 6
Material deformation 6
Failure to Adhere or Bond 5
Detachment of device component 4
Component(s), worn 4
Detachment of device or device component 4
Device or device fragments location unknown 3
Device-device incompatibility 3
Tip breakage 3
Device remains implanted 3
Device Issue 2
Corrosion 2
Component falling 2
Disengaged 2
Flaked 2
Dislodged or dislocated 2
Connection issue 2
Scratched material 2
Unintended movement 2
Material integrity issue 1
No Known Device Problem 1
Failure to separate 1
Defective item 1
Fluid leak 1
Migration of device or device component 1
Delivered as unsterile product 1
Particulates 1
Device Cleaning Issue 1
Failure to align 1
Dent in material 1
Device inoperable 1
Device damaged prior to use 1
Haptic(s), detached 1
Retraction problem 1
Slippage of device or device component 1
Failure to sterilize 1
Total Device Problems 1436

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

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Jan-30-2012
2 Encore Medical, Lp II Mar-08-2017
3 Encore Medical, Lp II Oct-30-2015
4 Encore Medical, Lp II Oct-10-2007
5 Greatbatch Medical I Nov-29-2016
6 Greatbatch Medical I Mar-06-2014
7 SpineFrontier, Inc. II Jun-05-2013
8 Stryker Howmedica Osteonics Corp. II Oct-07-2016
9 Stryker Howmedica Osteonics Corp. II Dec-27-2013
10 Stryker Howmedica Osteonics Corp. II Aug-27-2009
11 Stryker Howmedica Osteonics Corp. II Oct-20-2008
12 Stryker Howmedica Osteonics Corp. II May-14-2008
13 Zimmer Inc. II Sep-20-2008
14 Zimmer, Inc. II Nov-24-2014

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