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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device appliance, fixation, nail/blade/plate combination, multiple component
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeKTT
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED ORTHOPAEDIC SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
ALLIANCE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 9
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 3
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASCENT HEALTHCARE SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 3
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  1
  SUBSTANTIALLY EQUIVALENT 9
EBI, L.P.
  SUBSTANTIALLY EQUIVALENT 36
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HAND INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 2
KINAMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
MILLENNIUM
  SUBSTANTIALLY EQUIVALENT 1
NEWMEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
ONYX MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 3
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 8
PFIZER
  SUBSTANTIALLY EQUIVALENT 3
PIONEER
  SUBSTANTIALLY EQUIVALENT 1
PLUS ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 3
SMALL BONE INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 14
STERILMED
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 28
SURGICAL IMPLANT GENERATION NETWORK (SIGN)
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 32
TORNIER
  SUBSTANTIALLY EQUIVALENT 2
VANGUARD MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 11
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 10

Device Problems
No Known Device Problem 318
Break 187
Mechanical issue 118
Fracture 49
Implant, removal of 33
Unintended movement 31
No Information 29
Fitting problem 29
Device operates differently than expected 29
Migration of device or device component 28
Difficult to remove 20
Component(s), broken 17
Device remains implanted 14
Other (for use when an appropriate device code cannot be identified) 14
Unknown (for use when the device problem is not known) 9
Failure to align 9
Bent 9
Loose or intermittent connection 8
Material deformation 8
No code available 6
Mechanical jam 6
Loose 6
Peeled 6
Sticking 5
Material fragmentation 5
Dislodged or dislocated 5
Malfunction 4
Failure to Adhere or Bond 4
Displacement 4
Use of Device Issue 4
Metal shedding debris 3
Particulates 3
Corrosion 3
Material integrity issue 3
Malposition of device 3
Dull 3
Slippage of device or device component 2
Component missing 2
Positioning Issue 2
Detachment of device or device component 2
Material Distortion 2
Blockage within device or device component 2
Detachment of device component 2
Component incompatible 2
Disassembly 2
Device expiration issue 2
Explanted 1
Foreign material 1
Material erosion 1
Crack 1
Mislabeled 1
Misplacement 1
Device abrasion from instrument or another object 1
Improper or incorrect procedure or method 1
Interlock(s), failure of 1
Device, or device fragments remain in patient 1
Material separation 1
Size incorrect for patient 1
Foreign material present in device 1
Human-Device Interface Issue 1
Item contaminated during manufacturing or shipping 1
Material torqued 1
Mechanics altered 1
Naturally worn 1
Device Issue 1
Tear, rip or hole in device packaging 1
Patient-device incompatibility 1
Failure to advance 1
Device-device incompatibility 1
Difficult to advance 1
Difficult to open or close 1
Total Device Problems 1077

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 1 2 3 0 1 3 6 3 2 5 2
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II May-26-2016
2 Biomet, Inc. II Jun-09-2015
3 Biomet, Inc. II Dec-17-2012
4 Depuy Orthopaedics, Inc. II Jan-24-2008
5 Integra LifeSciences Corp. II Aug-11-2016
6 Integra LifeSciences Corp. II Jul-27-2016
7 Kinamed Inc II Jun-17-2011
8 Plus Orthopedics USA II Dec-08-2007
9 Small Bone Innovations, Inc. II Jun-04-2014
10 Sterilmed Inc II Jan-13-2009
11 Stryker Howmedica Osteonics Corp. II May-25-2017
12 Stryker Howmedica Osteonics Corp. II Jan-17-2013
13 Stryker Howmedica Osteonics Corp. II Nov-08-2012
14 Stryker Howmedica Osteonics Corp. II Aug-18-2009
15 Stryker Howmedica Osteonics Corp. II Sep-16-2008
16 Synthes (USA) Products LLC II Aug-24-2015
17 Synthes Spine II May-29-2009
18 Synthes USA HQ, Inc. II Dec-10-2013
19 Synthes USA HQ, Inc. II Nov-27-2013
20 Synthes USA HQ, Inc. II Sep-25-2013
21 Synthes USA HQ, Inc. II Mar-11-2013
22 Synthes USA HQ, Inc. II Nov-13-2012
23 Synthes, Inc. II Jun-19-2014
24 Zimmer Biomet, Inc. II Jun-15-2017
25 Zimmer Manufacturing B.V. II May-16-2016
26 Zimmer Manufacturing B.V. II Mar-12-2016
27 Zimmer, Inc. II Feb-20-2014
28 Zimmer, Inc. II Aug-26-2013

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