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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 385
Fracture 127
No code available 25
Material fragmentation 13
Malfunction 13
Crack 13
Component missing 11
Device, or device fragments remain in patient 11
Device, removal of (non-implant) 11
Disassembly 10
Difficult to remove 9
Sticking 9
Mechanical jam 9
Device operates differently than expected 7
Unknown (for use when the device problem is not known) 6
Failure to disconnect 6
Loose or intermittent connection 5
Failure to Adhere or Bond 4
Component(s), worn 4
No Information 4
Device or device fragments location unknown 3
Bent 3
Mechanical issue 3
Device remains implanted 3
Fitting problem 3
Tip breakage 3
Device Issue 2
Disengaged 2
Flaked 2
Detachment of device component 2
Component falling 2
Detachment of device or device component 2
Material deformation 2
Naturally worn 2
Scratched material 2
Unintended movement 1
No Known Device Problem 1
Device-device incompatibility 1
Dislodged or dislocated 1
Connection issue 1
Corrosion 1
Device Cleaning Issue 1
Migration of device or device component 1
Delivered as unsterile product 1
Particulates 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 737

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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