TPLC - Total Product Life Cycle

• Device: motor, surgical instrument, ac-powered
• Regulation Description: Surgical instrument motors and accessories/attachments.
• Product Code: GEY
• Regulation Number: 878.4820
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	1
AESCULAP
	SUBSTANTIALLY EQUIVALENT	1
ARTHROCARE CORP.
	SUBSTANTIALLY EQUIVALENT	1
DEPUY INTL., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INAMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
KARL STORZ GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
LINVATEC
	SUBSTANTIALLY EQUIVALENT	2
ORTHOPEDIC SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
THE ANSPACH EFFORT, INC.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems
Unintended system motion	445
Fail-safe mechanism issue	423
Device inoperable	310
Mechanical jam	249
Device operates differently than expected	125
Overheating of device or device component	64
Mechanical issue	60
Fluid leak	50
Noise, Audible	40
Failure to power-up	35
Sticking	29
Detachment of device component	26
Break	22
Loss of power	22
Loose or intermittent connection	18
Device stops intermittently	15
Leak	14
Component missing	12
Battery issue	11
Vibration	10
Difficult to position	10
Failure to charge	10
Temperature issue	10
Power source issue	10
Defective item	8
Defective component	7
Material separation	7
Component falling	7
Blockage within device or device component	7
Device displays error message	6
Connection issue	6
Failure to shut off	6
Slippage of device or device component	5
Difficult to remove	5
Air leak	5
Naturally worn	5
Output below specifications	4
Fracture	4
Power Conditioning Issue	4
Difficult to insert	4
Detachment of device or device component	4
Physical resistance	4
Device or device component damaged by another device	3
Device remains activated	3
Smoking	3
Fitting problem	3
Failure to Adhere or Bond	3
Bent	3
Material disintegration	3
Component incompatible	3
Crack	3
Hole in material	2
Unintended ejection	2
Self-activation or keying	2
Device contamination with blood or blood product	2
Failure to calibrate	2
Positioning Issue	2
No fail-safe mechanism	2
Torn material	2
Unintended movement	1
Misassembled by Users	1
Not Applicable	1
Device handling issue	1
Moisture or humidity problem	1
Pressure issue	1
Structural problem	1
Failure to disconnect	1
Difficult or delayed activation	1
Difficult to open or close	1
Manufacturing or shipping issue associated with device	1
Material deformation	1
Material integrity issue	1
Material torqued	1
Improper or incorrect procedure or method	1
Unraveled material	1
Inappropriate shock	1
Retraction problem	1
Material rupture	1
Melted	1
Moisture damage	1
Device emits odor	1
No device output	1
Application interface becomes non-functional or program exits abnormally	1
Decoupling	1
Decrease in suction	1
Unintended energization	1
Disassembly	1
Failure to discharge	1
Disconnection	1
Fail-safe design failure	1
Circuit Failure	1
Device clogged	1
Total Device Problems	2194

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	1	0	1	0	0	0	3	1	1	1
Class III	0	0	0	0	0	0	1	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Linvatec Corp. dba ConMed Linvatec	III	Mar-06-2013
2	Linvatec Corp. dba ConMed Linvatec	II	Jul-17-2010
3	MEDICAMAT S.A.	II	Mar-04-2014
4	Nico Corp.	II	Jun-21-2016
5	Nico Corp.	II	Sep-15-2015
6	Synthes U S A	II	Sep-21-2008
7	The Anspach Effort, Inc.	II	May-04-2017
8	The Anspach Effort, Inc.	II	Jun-25-2014
9	The Anspach Effort, Inc.	II	Jan-06-2014