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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device fastener, fixation, biodegradable, soft tissue
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeMAI
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 24
AXYA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOMET
  SUBSTANTIALLY EQUIVALENT 4
BIONX
  SUBSTANTIALLY EQUIVALENT 11
CONMED
  SUBSTANTIALLY EQUIVALENT 4
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 22
ETHICON
  1
  SUBSTANTIALLY EQUIVALENT 1
HOGAN & HARTSON L.L.P.
  SUBSTANTIALLY EQUIVALENT 1
INION
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
LINVATEC
  1
  SUBSTANTIALLY EQUIVALENT 12
MITEK
  SUBSTANTIALLY EQUIVALENT 4
SCANDIUS BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 10
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
SYNTHES
  SUBSTANTIALLY EQUIVALENT 2
TORNIER
  SUBSTANTIALLY EQUIVALENT 2
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  1
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 294
Unknown (for use when the device problem is not known) 66
Deployment issue 42
Tip breakage 35
No Information 30
No Known Device Problem 25
No code available 13
Material fragmentation 13
Difficult to deploy 7
Difficult to insert 6
Migration of device or device component 6
Detachment of device component 6
Device, or device fragments remain in patient 5
Component(s), broken 5
Bent 5
Use of Device Issue 4
Expulsion 3
Failure to Adhere or Bond 3
Failure to deploy 3
Absorption 2
Suture line separation 2
Implant, removal of 2
Device operates differently than expected 2
Difficult to advance 2
Dislodged or dislocated 2
Failure to disconnect 2
Patient-device incompatibility 1
Connection issue 1
Component missing 1
Device markings issue 1
Device Issue 1
Malfunction 1
Failure to advance 1
Tomographic pallet crack(s) 1
Unraveled material 1
Material disintegration 1
Device expiration issue 1
Explanted 1
Difficult to remove 1
Slippage of device or device component 1
Component falling 1
Crack 1
Nonstandard device or device component 1
Unsealed device packaging 1
Premature explantation 1
Material integrity issue 1
Total Device Problems 605

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 0 0 1 1 2 0 0 1 1
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II May-05-2017
2 DePuy Mitek, Inc., a Johnson & Johnson Co. II Mar-06-2012
3 DePuy Mitek, Inc., a Johnson & Johnson Co. II Nov-30-2011
4 Linvatec Corp. dba ConMed Linvatec II Jul-01-2013
5 Smith & Nephew, Inc. II Sep-07-2016
6 Smith & Nephew, Inc. Endoscopy Division II Sep-17-2013

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