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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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


Premarket Reviews
ManufacturerDecision
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

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