TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
ACCUMED SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
AMERICAN MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
ANULEX TECHNOLOGIES, INC
	SUBSTANTIALLY EQUIVALENT	3
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	11
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
ARTHROCARE CORP.
	SUBSTANTIALLY EQUIVALENT	22
ARTHROTEK, INC.
	SUBSTANTIALLY EQUIVALENT	5
AXYA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	5
BIOMET
	SUBSTANTIALLY EQUIVALENT	13
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	2
CAYENNE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	5
CONMED
	SUBSTANTIALLY EQUIVALENT	3
DEPUY INTL., LTD.
	SUBSTANTIALLY EQUIVALENT	5
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
	SUBSTANTIALLY EQUIVALENT	9
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
MITEK
	SUBSTANTIALLY EQUIVALENT	7
OPUSMED INC.
	SUBSTANTIALLY EQUIVALENT	3
SCANDIUS BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	2
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	18
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	6
SURGICRAFT CO.
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES
	SUBSTANTIALLY EQUIVALENT	2
THE ANSPACH EFFORT, INC.
	SUBSTANTIALLY EQUIVALENT	4
TORNIER
	SUBSTANTIALLY EQUIVALENT	4
W. LORENZ SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
WRIGHT MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	8
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Unknown (for use when the device problem is not known)	664
Break	199
Tip breakage	175
Device, or device fragments remain in patient	107
Device Issue	26
Failure to deploy	19
No Known Device Problem	16
Detachment of device component	13
Other (for use when an appropriate device code cannot be identified)	11
Fracture	11
Material fragmentation	11
Difficult to insert	10
No code available	6
Use of Device Issue	6
Loose	5
Difficult to deploy	4
Component(s), broken	3
Implant, removal of	3
Failure to deliver	3
Crack	2
Mechanical issue	2
Difficult to position	2
Failure to Adhere or Bond	2
Suture line separation	2
Malfunction	2
Migration of device or device component	2
Device remains implanted	2
Mechanical jam	1
Bent	1
Incomplete or missing packaging	1
Wire(s), breakage of	1
Pierce	1
Misfire	1
Circuit Failure	1
Material erosion	1
Tomographic pallet crack(s)	1
Misplacement	1
Device, removal of (non-implant)	1
Slippage of device or device component	1
Explanted	1
Linear	1
Defective item	1
Detachment of device or device component	1
Total Device Problems	1324

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	Aug-31-2011
7	Biomet, Inc.	II	Jul-01-2010
8	Biomet, Inc.	II	Dec-22-2009
9	DePuy Mitek, Inc., a Johnson & Johnson Co.	II	May-19-2011
10	Innovatech Medical Resources L.P.	II	Jan-11-2012
11	Linvatec Corp. dba ConMed Linvatec	II	Oct-15-2012
12	Linvatec Corp. dba ConMed Linvatec	II	Jun-29-2011
13	Smith & Nephew, Inc. Endoscopy Division	II	Aug-09-2012
14	Stryker Endoscopy	II	Aug-06-2008
15	Wright Medical Technology Inc	II	Oct-18-2011
16	Wright Medical Technology Inc	II	Mar-04-2011