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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 353
Leak 101
Bent 81
Overheating of device or device component 30
Unintended energization 26
Break 19
Fracture 15
Disassembly 11
Detachment of device component 10
Device inoperable 10
Device operates differently than expected 7
Noise, Audible 6
Air leak 6
Fluid leak 6
Mechanical issue 4
Vibration 4
Fitting problem 3
Unintended system motion 3
Unintended movement 3
Difficult to insert 3
Burst 3
Blockage within device or device component 2
Hole in material 2
Material rupture 2
Slippage of device or device component 2
Sticking 2
Device stops intermittently 2
No Information 2
Fail-safe mechanism issue 2
Material deformation 2
Mechanical jam 1
Output below specifications 1
Positioning Issue 1
Power source issue 1
Pressure issue 1
Foreign material present in device 1
Device-device incompatibility 1
Dislodged or dislocated 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
Metal shedding debris 1
Unstable 1
Smoking 1
Melted 1
Loss of power 1
Hose line rupture 1
Migration of device or device component 1
Misconnection 1
Occlusion within device 1
Burn of device or device component 1
Component falling 1
Component(s), worn 1
Corrosion 1
Material fragmentation 1
Material discolored 1
Failure, intermittent 1
Total Device Problems 750

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