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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device motor, drill, pneumatic
Regulation Description Pneumatic cranial drill motor.
Product CodeHBB
Regulation Number 882.4370
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
KOMET MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDICON, E.G.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
MICROMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Device abrasion from instrument or another object 335
Bent 78
Leak 48
Overheating of device or device component 18
Break 18
Unintended energization 18
Fracture 12
Detachment of device component 9
Device inoperable 8
Device operates differently than expected 7
Air leak 4
Burst 3
Fitting problem 3
Material deformation 2
No Information 2
Blockage within device or device component 2
Hole in material 2
Disassembly 2
Vibration 2
Material rupture 2
Mechanical issue 2
Fluid leak 2
Difficult to insert 2
Melted 1
Loss of power 1
Occlusion within device 1
Slippage of device or device component 1
Sticking 1
Device stops intermittently 1
Metal shedding debris 1
Unstable 1
Material discolored 1
Failure, intermittent 1
Hose line rupture 1
Material fragmentation 1
Burn of device or device component 1
Component(s), worn 1
Corrosion 1
Noise, Audible 1
Mechanical jam 1
Output below specifications 1
Positioning Issue 1
Power source issue 1
Pressure issue 1
Unknown (for use when the device problem is not known) 1
Physical resistance 1
Defective item 1
Detachment of device or device component 1
Device-device incompatibility 1
Dislodged or dislocated 1
Foreign material present in device 1
Total Device Problems 609

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

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Powered Surgical Solutions II Aug-23-2008
2 Medtronic Sofamor Danek Usa, Inc - Dallas Distribution II May-04-2016
3 Medtronic Sofamor Danek Usa, Inc - Dallas Distribution II Nov-20-2015
4 Medtronic Sofamor Danek Usa, Inc - Dallas Distribution II Dec-17-2009
5 Stryker Instruments Div. of Stryker Corporation II Jun-09-2016
6 The Anspach Effort, Inc. II Jun-25-2014
7 The Anspach Effort, Inc. II Jan-09-2014
8 The Anspach Effort, Inc. II Jul-11-2007

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