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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 2
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 222
Device inoperable 144
Break 110
Device displays error message 94
Device operates differently than expected 55
Temperature issue 37
Noise, Audible 36
Naturally worn 25
Difficult to insert 22
Defective item 21
Vibration 15
Component missing 14
Smoking 14
Fitting problem 12
Device stops intermittently 12
Sticking 11
Loss of power 11
Loose or intermittent connection 11
Bent 9
Failure to power-up 9
Material separation 9
Slippage of device or device component 8
Moisture damage 7
Detachment of device component 7
Crack 7
Positioning Issue 7
Detachment of device or device component 7
Component falling 5
Burn of device or device component 5
Corrosion 4
Fluid leak 4
Mechanical issue 4
Hole in material 4
Defective component 4
Power source issue 4
Material integrity issue 4
Mechanical jam 4
Torn material 4
Material deformation 4
Item contaminated during manufacturing or shipping 3
Leak 3
Fracture 3
Degraded 3
Air leak 2
Electrical issue 2
Self-activation or keying 2
Unstable 2
Device markings issue 2
Connection issue 2
No code available 2
Contamination of device ingredient or reagent 1
Device or device fragments location unknown 1
Malposition of device 1
Disinfection or Sterilization Issue at User Location 1
Metal shedding debris 1
Dull 1
Cut in material 1
Failure to advance 1
Split 1
Failure to cut 1
Material Distortion 1
Device sensing issue 1
Failure to auto stop 1
Failure to shut off 1
Foreign material present in device 1
Unintended movement 1
No Information 1
Mechanics altered 1
Occlusion within device 1
Device emits odor 1
Peeled 1
Device remains activated 1
Difficult to remove 1
Material fragmentation 1
Migration of device or device component 1
Device alarm system issue 1
Burst 1
Erratic display 1
Total Device Problems 1040

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 3 0 1 2 1 0
Class III 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 Feb-02-2015
3 The Anspach Effort, Inc. II Jun-25-2014
4 The Anspach Effort, Inc. II Jan-27-2014
5 The Anspach Effort, Inc. II Nov-13-2013
6 The Anspach Effort, Inc. II Sep-14-2011
7 The Anspach Effort, Inc. II Sep-13-2011

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