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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 1659
Fracture 183
No code available 99
Crack 82
Material fragmentation 24
Disassembly 23
Difficult to remove 20
Connection issue 20
Component missing 19
Mechanical jam 17
Device operates differently than expected 16
Failure to disconnect 16
Malfunction 13
Mechanical issue 12
Loose or intermittent connection 11
Device, or device fragments remain in patient 11
Device, removal of (non-implant) 11
No Information 11
Naturally worn 10
Sticking 10
Bent 9
Detachment of device component 9
Fitting problem 7
Material deformation 7
Detachment of device or device component 6
Unknown (for use when the device problem is not known) 6
Failure to Adhere or Bond 5
Component(s), worn 4
Tip breakage 3
Device remains implanted 3
Device-device incompatibility 3
Device or device fragments location unknown 3
Defective item 2
Dislodged or dislocated 2
Scratched material 2
Unintended movement 2
Device Issue 2
Dull 2
Corrosion 2
Component falling 2
Disengaged 2
Flaked 2
Fluid leak 1
Failure to discharge 1
Haptic(s), detached 1
Imprecision 1
Difficult to insert 1
Device Cleaning Issue 1
Device damaged prior to use 1
Device inoperable 1
Migration of device or device component 1
Delivered as unsterile product 1
Particulates 1
Retraction problem 1
Slippage of device or device component 1
Failure to sterilize 1
Material integrity issue 1
No Known Device Problem 1
Positioning Issue 1
Failure to align 1
Dent in material 1
Failure to separate 1
Total Device Problems 2372

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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