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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device nail, fixation, bone
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeJDS
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC DESIGNS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 8
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 11
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 199
Break 96
Fracture 30
Migration of device or device component 17
Fitting problem 14
Device operates differently than expected 14
No code available 12
Device, or device fragments remain in patient 10
Bent 9
Implant, removal of 9
No Information 9
Unknown (for use when the device problem is not known) 8
Sticking 8
Malfunction 7
Failure to align 7
Device remains implanted 6
Explanted 6
Difficult to remove 5
Other (for use when an appropriate device code cannot be identified) 5
Mechanical jam 5
Unintended movement 5
Failure to Adhere or Bond 4
Component(s), broken 3
Difficult to position 3
Device Issue 3
Failure to separate 3
Tear, rip or hole in device packaging 2
Dislodged or dislocated 2
Material deformation 2
Material fragmentation 2
Loose or intermittent connection 2
Disengaged 2
Crack 2
Packaging issue 2
Positioning Issue 1
Degraded 1
Material discolored 1
Detachment of device component 1
Loose 1
Difficult to insert 1
Shelf life exceeded 1
Material Protrusion 1
Malposition of device 1
Total Device Problems 522

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 1 0 0 3 2 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Smith & Nephew Inc II May-20-2014
2 Smith & Nephew Inc II Mar-13-2013
3 Smith & Nephew, Inc. II Aug-17-2014
4 Stryker Howmedica Osteonics Corp. II Jun-01-2009
5 Synthes (USA) Products LLC II Nov-26-2013
6 Synthes USA (HQ), Inc. II May-07-2010
7 Synthes USA HQ, Inc. II Nov-27-2013
8 Synthes, Inc. II Jul-08-2015

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