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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 315
Break 124
Migration of device or device component 41
Fracture 33
Fitting problem 21
No code available 18
Device operates differently than expected 17
Unintended movement 14
No Information 13
Failure to align 13
Bent 13
Device, or device fragments remain in patient 10
Implant, removal of 9
Mechanical jam 9
Sticking 8
Unknown (for use when the device problem is not known) 8
Malfunction 7
Difficult to remove 7
Explanted 6
Device remains implanted 6
Failure to Adhere or Bond 5
Other (for use when an appropriate device code cannot be identified) 5
Detachment of device or device component 5
Material fragmentation 4
Loose or intermittent connection 3
Difficult to position 3
Component(s), broken 3
Device Issue 3
Failure to separate 3
Dislodged or dislocated 2
Material deformation 2
Tear, rip or hole in device packaging 2
Crack 2
Disengaged 2
Packaging issue 2
Positioning Issue 1
Device expiration issue 1
Degraded 1
Material discolored 1
Detachment of device component 1
Loose 1
Difficult to insert 1
Shelf life exceeded 1
Failure to osseointegrate 1
Material Protrusion 1
Malposition of device 1
Total Device Problems 749

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 1 0 0 3 2 1 0 0
Class III 0 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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