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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 1142
Fracture 191
Material fragmentation 103
Tip breakage 102
Device operates differently than expected 98
Dull 50
Device, or device fragments remain in patient 49
No code available 43
Material deformation 42
Bent 35
Naturally worn 26
Crack 16
Fitting problem 15
Failure to Adhere or Bond 15
Malfunction 14
Material Distortion 12
Mechanical issue 11
Detachment of device component 10
Failure to shut off 9
Device inoperable 9
Continuous firing 9
No Known Device Problem 8
Component missing 8
Difficult to remove 8
Slippage of device or device component 8
Difficult to insert 6
Material twisted 6
Device stops intermittently 6
Loose or intermittent connection 5
Device or device fragments location unknown 5
Device, removal of (non-implant) 5
Material separation 5
Mechanical jam 5
Device handling issue 4
Device damaged prior to use 4
Material integrity issue 4
Shipping damage or problem 4
Use of Device Issue 3
Connection issue 3
Device remains activated 3
Manufacturing or shipping issue associated with device 3
Failure to disconnect 3
Detachment of device or device component 3
No Information 3
Sticking 3
Peeled 2
Foreign material present in device 2
Device-device incompatibility 2
Failure to power-up 2
Device Issue 2
Torn material 2
Component(s), broken 2
Failure to align 2
Defective item 2
Difficult to advance 2
Output above specifications 2
Electrical issue 2
Metal shedding debris 2
Disassembly 2
Unknown (for use when the device problem is not known) 2
Corrosion 2
Device Cleaning Issue 2
Noise 1
Blank screen 1
Incompatibility problem 1
Power source issue 1
Defective component 1
Improper or incorrect procedure or method 1
Degraded 1
Particulates 1
Failure to recalibrate 1
Dislodged or dislocated 1
Buckled material 1
Failure to calibrate 1
Replace 1
Failure to run on portable mode 1
Residue after decontamination 1
Unraveled material 1
Material frayed 1
Component falling 1
Mechanics altered 1
Torqued 1
Component(s), worn 1
Calibration error 1
Device markings issue 1
Other (for use when an appropriate device code cannot be identified) 1
Implant, removal of 1
Noise, Audible 1
Timer failure 1
Output issue 1
Bolus mechanism failure 1
Dissatisfaction 1
Device or device component damaged by another device 1
Failure to deliver energy 1
Device remains implanted 1
Material Protrusion 1
Normal 1
Loose 1
Contamination of device ingredient or reagent 1
Shaft break 1
Total Device Problems 2188

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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