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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 1658
Fracture 256
Material fragmentation 150
Dull 133
No code available 117
Device operates differently than expected 114
Tip breakage 102
Material deformation 84
Naturally worn 63
Bent 58
Device, or device fragments remain in patient 49
Failure to Adhere or Bond 36
Crack 27
Fitting problem 21
Material twisted 21
Peeled 20
Material Distortion 16
Mechanical issue 15
Detachment of device component 14
Malfunction 14
Component missing 11
Device inoperable 11
Disassembly 11
No Known Device Problem 10
Failure to shut off 9
Foreign material present in device 9
Connection issue 9
Continuous firing 9
Difficult to remove 9
Slippage of device or device component 8
Device stops intermittently 6
Device damaged prior to use 6
Difficult to insert 6
Loose or intermittent connection 6
Device-device incompatibility 6
Device or device fragments location unknown 5
Device, removal of (non-implant) 5
Mechanical jam 5
Device handling issue 5
Sticking 5
Material separation 5
Shipping damage or problem 4
Use of Device Issue 3
Failure to align 3
Failure to disconnect 3
Device remains activated 3
No Information 3
Manufacturing or shipping issue associated with device 3
Detachment of device or device component 3
Material integrity issue 3
Difficult to advance 2
Device markings issue 2
Calibration issue 2
Torn material 2
Failure to power-up 2
Output above specifications 2
Corrosion 2
Electrical issue 2
Component(s), broken 2
Calibration error 2
Device Cleaning Issue 2
Defective item 2
Unknown (for use when the device problem is not known) 2
Device Issue 2
Metal shedding debris 2
Fluid leak 2
Shaft break 1
Timer failure 1
Improper or incorrect procedure or method 1
Noise 1
Unraveled material 1
Torqued 1
Implant, removal of 1
Residue after decontamination 1
Defective component 1
Other (for use when an appropriate device code cannot be identified) 1
Failure to advance 1
Dissatisfaction 1
Failure to calibrate 1
Device clogged 1
Blank screen 1
Bolus mechanism failure 1
Failure to deliver energy 1
Material discolored 1
Component falling 1
Component(s), worn 1
Unsealed device packaging 1
Particulates 1
Poor quality image 1
Normal 1
Loose 1
Material frayed 1
Failure to recalibrate 1
Failure to run on portable mode 1
Device remains implanted 1
Replace 1
Unintended movement 1
Noise, Audible 1
Mechanics altered 1
Output issue 1
Total Device Problems 3218

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