TPLC - Total Product Life Cycle

Device	bit, drill
Regulation Description	Orthopedic manual surgical instrument.
Product Code	HTW
Regulation Number	888.4540
Device Class	1

Device Problems
Fracture	121
Unknown (for use when the device problem is not known)	103
Break	62
Device, or device fragments remain in patient	51
Tip breakage	18
Device, removal of (non-implant)	6
Metal shedding debris	6
Component(s), broken	5
Other (for use when an appropriate device code cannot be identified)	4
Device remains implanted	4
Detachment of device component	4
Malfunction	4
Delivered as unsterile product	2
Shaft break	2
Material integrity issue	2
Motion detector failure	1
Failure to Adhere or Bond	1
Loose	1
Device remains activated	1
Burrs, breakage of	1
Difficult to insert	1
No Known Device Problem	1
Difficult to remove	1
Device Issue	1
Material fragmentation	1
Implant, removal of	1
Crack	1
Device abrasion from instrument or another object	1
Retraction problem	1
Use of Device Issue	1
Total Device Problems	409

Recalls
Manufacturer		Recall Class	Date Posted
1	Exactech, Inc.	II	Sep-11-2012
2	Integra LifeSciences Corp.	II	Jan-09-2007
3	Intelifuse Inc	II	Mar-05-2009
4	Interventional Spine Inc	II	Jan-11-2012
5	Linvatec Corp. dba ConMed Linvatec	II	Nov-19-2012
6	Orthohelix Surgical Designs Inc	II	Apr-22-2010
7	Smith & Nephew Inc	II	Jun-06-2012
8	Sterilmed Inc	II	Jan-13-2009
9	Synthes USA (HQ), Inc.	II	Jan-11-2012
10	The Anspach Effort, Inc.	II	Jul-25-2012