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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 420
Fracture 129
No code available 26
Material fragmentation 15
Malfunction 13
Crack 13
Disassembly 11
Component missing 11
Device, or device fragments remain in patient 11
Device, removal of (non-implant) 11
Mechanical jam 10
Difficult to remove 10
Sticking 9
Device operates differently than expected 8
Failure to disconnect 7
Unknown (for use when the device problem is not known) 6
Loose or intermittent connection 5
Mechanical issue 4
Failure to Adhere or Bond 4
Component(s), worn 4
No Information 4
Device or device fragments location unknown 3
Detachment of device component 3
Bent 3
Device remains implanted 3
Fitting problem 3
Tip breakage 3
Device Issue 2
Component falling 2
Disengaged 2
Flaked 2
Detachment of device or device component 2
Material deformation 2
Naturally worn 2
Scratched material 2
Unintended movement 2
No Known Device Problem 1
Device-device incompatibility 1
Dislodged or dislocated 1
Connection issue 1
Migration of device or device component 1
Delivered as unsterile product 1
Particulates 1
Corrosion 1
Device Cleaning Issue 1
Failure to separate 1
Defective item 1
Failure to align 1
Dent in material 1
Metal shedding debris 1
Haptic(s), detached 1
Retraction problem 1
Slippage of device or device component 1
Failure to sterilize 1
Total Device Problems 785

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 1 0 0
Class II 1 3 1 0 0 1 2 1 1 0
Class III 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 Oct-30-2015
3 Encore Medical, Lp II Oct-10-2007
4 Greatbatch Medical I Mar-06-2014
5 SpineFrontier, Inc. II Jun-05-2013
6 Stryker Howmedica Osteonics Corp. II Dec-27-2013
7 Stryker Howmedica Osteonics Corp. II Aug-27-2009
8 Stryker Howmedica Osteonics Corp. II Oct-20-2008
9 Stryker Howmedica Osteonics Corp. II May-14-2008
10 Zimmer Inc. II Sep-20-2008
11 Zimmer, Inc. II Nov-24-2014

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