TPLC - Total Product Life Cycle

Device	screwdriver
Regulation Description	Orthopedic manual surgical instrument.
Product Code	HXX
Regulation Number	888.4540
Device Class	1

Device Problems
Break	309
Tip breakage	102
Device, or device fragments remain in patient	49
Fracture	41
Malfunction	14
Difficult to insert	5
Device, removal of (non-implant)	5
Device inoperable	4
Naturally worn	4
Crack	4
Slippage of device or device component	3
Material fragmentation	3
Difficult to remove	2
Detachment of device component	2
Foreign material present in device	2
Unknown (for use when the device problem is not known)	2
Implant, removal of	1
Component(s), broken	1
Timer failure	1
Use of Device Issue	1
Metal shedding debris	1
Other (for use when an appropriate device code cannot be identified)	1
Bolus mechanism failure	1
Component(s), worn	1
Material frayed	1
Replace	1
Torqued	1
Dull	1
Failure to disconnect	1
Connection issue	1
No Known Device Problem	1
Material integrity issue	1
Loose	1
Poor quality image	1
Normal	1
Shaft break	1
Sticking	1
Blank screen	1
Noise	1
Dissatisfaction	1
Device or device component damaged by another device	1
Mechanical jam	1
Bent	1
Device Cleaning Issue	1
Total Device Problems	579

Recalls
Manufacturer		Recall Class	Date Posted
1	Ascension Orthopedics, Inc	II	Jun-26-2009
2	Biomet, Inc.	II	Sep-28-2012
3	Ebi, Llc	II	Mar-15-2013
4	Ebi, Llc	II	Dec-17-2012
5	Interventional Spine Inc	II	Oct-13-2011
6	Stryker Howmedica Osteonics Corp.	II	Sep-16-2008
7	Stryker Spine	II	Sep-19-2008
8	Wright Medical Technology Inc	II	Sep-22-2010
9	Zimmer Inc.	II	Jul-06-2011