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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 578
Fracture 131
No code available 27
Crack 25
Material fragmentation 16
Malfunction 13
Disassembly 13
Mechanical jam 12
Device, removal of (non-implant) 11
Device operates differently than expected 11
Component missing 11
Device, or device fragments remain in patient 11
Difficult to remove 10
Sticking 9
Loose or intermittent connection 7
Failure to disconnect 7
Fitting problem 6
Unknown (for use when the device problem is not known) 6
No Information 5
Mechanical issue 4
Failure to Adhere or Bond 4
Detachment of device component 4
Component(s), worn 4
Bent 3
Tip breakage 3
Naturally worn 3
Material deformation 3
Device remains implanted 3
Device or device fragments location unknown 3
Detachment of device or device component 2
Scratched material 2
Unintended movement 2
Device Issue 2
Corrosion 2
Component falling 2
Disengaged 2
Flaked 2
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
Haptic(s), detached 1
Device inoperable 1
Metal shedding debris 1
Retraction problem 1
Slippage of device or device component 1
Failure to sterilize 1
Material integrity issue 1
No Known Device Problem 1
Failure to separate 1
Defective item 1
Device-device incompatibility 1
Dislodged or dislocated 1
Connection issue 1
Total Device Problems 978

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 1 0 1
Class II 1 3 1 0 0 1 2 1 1 1
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 Nov-29-2016
5 Greatbatch Medical I Mar-06-2014
6 SpineFrontier, Inc. II Jun-05-2013
7 Stryker Howmedica Osteonics Corp. II Oct-07-2016
8 Stryker Howmedica Osteonics Corp. II Dec-27-2013
9 Stryker Howmedica Osteonics Corp. II Aug-27-2009
10 Stryker Howmedica Osteonics Corp. II Oct-20-2008
11 Stryker Howmedica Osteonics Corp. II May-14-2008
12 Zimmer Inc. II Sep-20-2008
13 Zimmer, Inc. II Nov-24-2014

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