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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 755
Fracture 117
Tip breakage 102
Device operates differently than expected 66
Device, or device fragments remain in patient 49
Material fragmentation 46
Dull 32
Material deformation 23
No code available 21
Naturally worn 15
Bent 15
Malfunction 14
Failure to Adhere or Bond 11
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
Device stops intermittently 6
Fitting problem 6
Device, removal of (non-implant) 5
Difficult to insert 5
Material twisted 5
Material Distortion 5
Device handling issue 4
Device or device fragments location unknown 4
Component missing 4
Device inoperable 4
Shipping damage or problem 4
Device damaged prior to use 4
Failure to disconnect 3
Sticking 3
Device remains activated 3
Material integrity issue 3
Foreign material present in device 2
Manufacturing or shipping issue associated with device 2
Difficult to advance 2
Torn material 2
No Information 2
Mechanical jam 2
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
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
Mechanics altered 1
Power source issue 1
Noise, Audible 1
Dislodged or dislocated 1
Material Protrusion 1
Total Device Problems 1473

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 0
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 Interventional Spine Inc II Oct-13-2011
8 Medtronic Sofamor Danek USA Inc II Jan-30-2014
9 Medtronic Sofamor Danek USA Inc II Sep-14-2013
10 SpineFrontier, Inc. II Aug-13-2013
11 SpineFrontier, Inc. II Aug-08-2013
12 SpineFrontier, Inc. II Aug-08-2013
13 SpineFrontier, Inc. II Jul-05-2013
14 Stryker Howmedica Osteonics Corp. II Sep-16-2008
15 Stryker Spine II Sep-19-2008
16 Wright Medical Technology Inc II Sep-22-2010
17 Zimmer Inc. II Jul-06-2011

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