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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device motor, drill, electric
Regulation Description Electric cranial drill motor.
Product CodeHBC
Regulation Number 882.4360
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 3
BIOPLATE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONMED
  SUBSTANTIALLY EQUIVALENT 1
LINVATEC
  SUBSTANTIALLY EQUIVALENT 2
MEDICON, E.G.
  SUBSTANTIALLY EQUIVALENT 1
NAKANISHI, INC.
  SUBSTANTIALLY EQUIVALENT 2
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Overheating of device or device component 470
Device inoperable 148
Device displays error message 115
Break 112
Bent 77
Device operates differently than expected 69
Vibration 63
Noise, Audible 46
Fail-safe mechanism issue 44
Unintended system motion 43
Temperature issue 37
Difficult to insert 26
Naturally worn 25
Mechanical issue 23
Detachment of device component 21
Defective item 21
Material separation 18
Device stops intermittently 16
Fracture 15
Smoking 14
Component missing 14
Loose or intermittent connection 13
Fitting problem 12
Sticking 11
Loss of power 11
Failure to power-up 9
Difficult to position 9
Detachment of device or device component 9
Slippage of device or device component 8
Fluid leak 8
Crack 7
Moisture damage 7
Positioning Issue 7
Component falling 6
Burn of device or device component 5
Material deformation 5
Mechanical jam 5
Torn material 4
Power source issue 4
Material integrity issue 4
Defective component 4
Corrosion 4
Hole in material 4
Degraded 3
Electrical issue 3
Leak 3
Item contaminated during manufacturing or shipping 3
Output below specifications 3
No code available 2
Device markings issue 2
Connection issue 2
Self-activation or keying 2
Unstable 2
Air leak 2
Device alarm system issue 1
Burst 1
Erratic display 1
Material fragmentation 1
Entrapment of device or device component 1
Migration of device or device component 1
Occlusion within device 1
Device emits odor 1
Peeled 1
Device remains activated 1
Difficult to remove 1
Metal shedding debris 1
Device or device fragments location unknown 1
Dull 1
Cut in material 1
Structural problem 1
Failure to advance 1
Split 1
Failure to cut 1
Contamination of device ingredient or reagent 1
Malposition of device 1
Disinfection or Sterilization Issue at User Location 1
Device sensing issue 1
Electrical power problem 1
Material Distortion 1
Failure to auto stop 1
Failure to shut off 1
Foreign material present in device 1
Mechanics altered 1
Unintended movement 1
No Information 1
Total Device Problems 1631

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 0 0 0 3 0 1 2 1 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Inc II Mar-02-2011
2 The Anspach Effort, Inc. II Jul-21-2016
3 The Anspach Effort, Inc. II Feb-02-2015
4 The Anspach Effort, Inc. II Jun-25-2014
5 The Anspach Effort, Inc. II Jan-27-2014
6 The Anspach Effort, Inc. II Nov-13-2013
7 The Anspach Effort, Inc. II Sep-14-2011
8 The Anspach Effort, Inc. II Sep-13-2011

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