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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device fastener, fixation, nondegradable, soft tissue
Regulation Description Smooth or threaded metallic bone fixation fastener.
Product CodeMBI
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ANULEX TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 3
ARTHREX, INC.
  1
  SUBSTANTIALLY EQUIVALENT 17
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 33
ARTHROTEK, INC.
  SUBSTANTIALLY EQUIVALENT 5
AXYA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
BIOMET
  SUBSTANTIALLY EQUIVALENT 19
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
CAYENNE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 8
CONMED
  SUBSTANTIALLY EQUIVALENT 5
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 9
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
DJ ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 2
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 1
IMPLEX
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
LINVATEC
  1
  SUBSTANTIALLY EQUIVALENT 9
MITEK
  SUBSTANTIALLY EQUIVALENT 7
OPUSMED INC.
  SUBSTANTIALLY EQUIVALENT 3
PARCUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 8
SCANDIUS BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 20
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 8
SURGICRAFT CO.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 2
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 4
TORNIER
  SUBSTANTIALLY EQUIVALENT 7
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  1
  SUBSTANTIALLY EQUIVALENT 9
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Unknown (for use when the device problem is not known) 670
Break 264
Tip breakage 175
Device, or device fragments remain in patient 107
No Known Device Problem 79
Fracture 42
Deployment issue 34
Failure to deploy 33
Detachment of device component 28
Device Issue 26
Migration of device or device component 23
Material fragmentation 17
No Information 16
Difficult to insert 12
Other (for use when an appropriate device code cannot be identified) 11
Device operates differently than expected 10
No code available 8
Use of Device Issue 7
Unintended movement 6
Dislodged or dislocated 6
Bent 6
Loose or intermittent connection 6
Loose 5
Difficult to deploy 5
Positioning Issue 5
Detachment of device or device component 4
Failure to deliver 4
Slippage of device or device component 4
Mechanical issue 4
Crack 4
Component(s), broken 3
Failure to Adhere or Bond 3
Difficult to remove 3
Improper or incorrect procedure or method 3
Implant, removal of 3
Component or accessory incompatibility 3
Device-device incompatibility 2
Torn material 2
Patient-device incompatibility 2
Mechanical jam 2
Component missing 2
Malfunction 2
Misfire 2
Device remains implanted 2
Sticking 2
Suture line separation 2
Difficult to position 2
Material puncture 1
Product quality issue 1
Misassembled 1
Misplacement 1
Pierce 1
Tomographic pallet crack(s) 1
Circuit Failure 1
Component falling 1
Contamination during use 1
Linear 1
Disassembly 1
Entrapment of device or device component 1
Material erosion 1
Explanted 1
Failure to disconnect 1
Defective item 1
Device or device fragments location unknown 1
Device, removal of (non-implant) 1
Failure to fire 1
Malposition of device 1
Cut in material 1
Wire(s), breakage of 1
Incomplete or missing packaging 1
Fitting problem 1
Metal shedding debris 1
Material Protrusion 1
Scratched material 1
Difficult to advance 1
Device or device component damaged by another device 1
Device packaging compromised 1
Contamination of device ingredient or reagent 1
Noise, Audible 1
Total Device Problems 1693

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 1 3 1 1 6 4 3 3 1 3
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 American Medical Systems II Jul-16-2008
2 ArthroCare Corporation II Apr-12-2011
3 Axya Medical II Dec-08-2007
4 Biomet Sports Medicine II Jan-11-2012
5 Biomet Sports Medicine II Sep-04-2008
6 Biomet, Inc. II May-26-2016
7 Biomet, Inc. II Nov-19-2013
8 Biomet, Inc. II Aug-31-2011
9 Biomet, Inc. II Jul-01-2010
10 Biomet, Inc. II Dec-22-2009
11 DePuy Mitek, Inc., a Johnson & Johnson Co. II May-19-2011
12 EXP Pharmaceutical Services Corp II Jul-24-2015
13 Innovatech Medical Resources L.P. II Jan-11-2012
14 Linvatec Corp. dba ConMed Linvatec II Oct-15-2012
15 Linvatec Corp. dba ConMed Linvatec II Jun-29-2011
16 Medshape Solutions, INC. II May-08-2013
17 OrthoPediatrics Corp II Aug-29-2014
18 OrthoPediatrics Corp II Dec-26-2013
19 Smith & Nephew, Inc. Endoscopy Division II Jul-14-2014
20 Smith & Nephew, Inc. Endoscopy Division II Aug-09-2012
21 Stryker Corporation II May-10-2016
22 Stryker Endoscopy II Aug-06-2008
23 Synthes (USA) Products LLC II Jul-07-2016
24 The Anspach Effort, Inc. II Jun-25-2014
25 Wright Medical Technology Inc II Oct-18-2011
26 Wright Medical Technology Inc II Mar-04-2011

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