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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 386
Device inoperable 148
Device displays error message 112
Break 112
Device operates differently than expected 68
Bent 49
Noise, Audible 44
Vibration 42
Temperature issue 37
Fail-safe mechanism issue 30
Unintended system motion 29
Difficult to insert 25
Naturally worn 25
Defective item 21
Device stops intermittently 16
Material separation 16
Mechanical issue 16
Detachment of device component 15
Smoking 14
Component missing 14
Fitting problem 12
Loose or intermittent connection 12
Loss of power 11
Fracture 11
Sticking 11
Detachment of device or device component 9
Failure to power-up 9
Slippage of device or device component 8
Moisture damage 7
Fluid leak 7
Crack 7
Positioning Issue 7
Difficult to position 6
Component falling 5
Burn of device or device component 5
Material deformation 5
Material integrity issue 4
Mechanical jam 4
Defective component 4
Corrosion 4
Hole in material 4
Power source issue 4
Torn material 4
Item contaminated during manufacturing or shipping 3
Degraded 3
Electrical issue 3
Leak 3
Air leak 2
Self-activation or keying 2
Unstable 2
Device markings issue 2
Connection issue 2
No code available 2
Unintended movement 1
No Information 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
Mechanics altered 1
Material Distortion 1
Failure to auto stop 1
Failure to shut off 1
Foreign material present in device 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
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
Total Device Problems 1434

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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