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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device screwdriver
Regulation Description Orthopedic manual surgical instrument.
Product CodeHXX
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 797
Fracture 126
Tip breakage 102
Device operates differently than expected 70
Material fragmentation 55
Device, or device fragments remain in patient 49
Dull 38
Material deformation 25
No code available 23
Bent 20
Naturally worn 16
Malfunction 14
Failure to Adhere or Bond 13
Crack 10
Continuous firing 9
Failure to shut off 9
No Known Device Problem 8
Difficult to remove 8
Slippage of device or device component 8
Mechanical issue 7
Detachment of device component 7
Difficult to insert 6
Device stops intermittently 6
Fitting problem 6
Material Distortion 6
Material twisted 5
Device inoperable 5
Device, removal of (non-implant) 5
Component missing 4
Shipping damage or problem 4
Device damaged prior to use 4
Device handling issue 4
Device or device fragments location unknown 4
Mechanical jam 3
Material integrity issue 3
Failure to disconnect 3
Sticking 3
Device remains activated 3
Failure to power-up 2
Component(s), broken 2
Corrosion 2
Disassembly 2
Electrical issue 2
Defective item 2
Connection issue 2
Detachment of device or device component 2
Unknown (for use when the device problem is not known) 2
Use of Device Issue 2
Metal shedding debris 2
Foreign material present in device 2
Manufacturing or shipping issue associated with device 2
Difficult to advance 2
Torn material 2
No Information 2
Noise, Audible 1
Mechanics altered 1
Power source issue 1
Dislodged or dislocated 1
Material Protrusion 1
Improper or incorrect procedure or method 1
Noise 1
Timer failure 1
Torqued 1
Defective component 1
Unraveled material 1
Other (for use when an appropriate device code cannot be identified) 1
Device markings issue 1
Device or device component damaged by another device 1
Contamination of device ingredient or reagent 1
Implant, removal of 1
Residue after decontamination 1
Device Issue 1
Dissatisfaction 1
Failure to calibrate 1
Failure to align 1
Failure to deliver energy 1
Material frayed 1
Component falling 1
Component(s), worn 1
Blank screen 1
Bolus mechanism failure 1
Device Cleaning Issue 1
Failure to recalibrate 1
Loose or intermittent connection 1
Loose 1
Poor quality image 1
Normal 1
Particulates 1
Failure to run on portable mode 1
Device remains implanted 1
Replace 1
Material separation 1
Shaft break 1
Total Device Problems 1559

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 2 1 1 2 2 7 2 0 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ascension Orthopedics, Inc II Jun-26-2009
2 Biomet, Inc. II Sep-28-2012
3 Ebi, Llc II Jun-17-2014
4 Ebi, Llc II Nov-27-2013
5 Ebi, Llc II Mar-15-2013
6 Ebi, Llc II Dec-17-2012
7 Greatbatch Medical II Jun-01-2016
8 Interventional Spine Inc II Oct-13-2011
9 Medtronic Sofamor Danek USA Inc II Jan-30-2014
10 Medtronic Sofamor Danek USA Inc II Sep-14-2013
11 Orthofix, Inc II Jun-01-2016
12 SpineFrontier, Inc. II Aug-13-2013
13 SpineFrontier, Inc. II Aug-08-2013
14 SpineFrontier, Inc. II Aug-08-2013
15 SpineFrontier, Inc. II Jul-05-2013
16 Stryker Howmedica Osteonics Corp. II Sep-16-2008
17 Stryker Spine II Sep-19-2008
18 Wright Medical Technology Inc II Sep-22-2010
19 Zimmer Inc. II Jul-06-2011

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