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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 281
Fracture 126
No code available 17
Malfunction 13
Crack 12
Material fragmentation 11
Device, or device fragments remain in patient 11
Device, removal of (non-implant) 11
Difficult to remove 9
Sticking 9
Disassembly 7
Mechanical jam 7
Device operates differently than expected 6
Unknown (for use when the device problem is not known) 6
Failure to disconnect 6
Component missing 4
Failure to Adhere or Bond 4
Component(s), worn 4
Bent 3
Loose or intermittent connection 3
Device remains implanted 3
Device or device fragments location unknown 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
No Information 2
Dislodged or dislocated 1
Material deformation 1
No Known Device Problem 1
Scratched material 1
Unintended movement 1
Corrosion 1
Device Cleaning Issue 1
Mechanical issue 1
Migration of device or device component 1
Delivered as unsterile product 1
Failure to align 1
Failure to separate 1
Defective item 1
Metal shedding debris 1
Fitting problem 1
Failure to sterilize 1
Haptic(s), detached 1
Total Device Problems 590

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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