TPLC - Total Product Life Cycle

• Device: nail, fixation, bone
• Regulation Description: Single/multiple component metallic bone fixation appliances and accessories.
• Product Code: JDS
• Regulation Number: 888.3030
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
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
Break	17
Fracture	17
Device, or device fragments remain in patient	10
Implant, removal of	9
Unknown (for use when the device problem is not known)	8
Malfunction	7
Explanted	6
Device remains implanted	6
Other (for use when an appropriate device code cannot be identified)	5
Fitting problem	4
Component(s), broken	3
Failure to Adhere or Bond	2
Disengaged	2
Device Issue	2
Tear, rip or hole in device packaging	2
Detachment of device component	1
Difficult to insert	1
Loose	1
Difficult to remove	1
Device operates differently than expected	1
Dislodged or dislocated	1
No Information	1
No code available	1
Total Device Problems	108

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	0	0	1	1	0	0	1
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Smith & Nephew Inc	II	Mar-13-2013
2	Stryker Howmedica Osteonics Corp.	II	Jun-01-2009
3	Synthes USA (HQ), Inc.	II	May-07-2010