• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 1089
Fracture 179
Tip breakage 102
Material fragmentation 101
Device operates differently than expected 96
Device, or device fragments remain in patient 49
Dull 46
No code available 36
Material deformation 34
Bent 28
Naturally worn 22
Crack 16
Failure to Adhere or Bond 14
Malfunction 14
Fitting problem 13
Mechanical issue 10
Detachment of device component 10
Continuous firing 9
Device inoperable 9
Material Distortion 9
Failure to shut off 9
No Known Device Problem 8
Slippage of device or device component 8
Difficult to remove 8
Component missing 7
Device stops intermittently 6
Difficult to insert 6
Material twisted 6
Mechanical jam 5
Loose or intermittent connection 5
Device, removal of (non-implant) 5
Device damaged prior to use 4
Shipping damage or problem 4
Device handling issue 4
Material integrity issue 4
Device or device fragments location unknown 4
Manufacturing or shipping issue associated with device 3
No Information 3
Material separation 3
Device remains activated 3
Use of Device Issue 3
Sticking 3
Failure to disconnect 3
Connection issue 3
Detachment of device or device component 3
Defective item 2
Unknown (for use when the device problem is not known) 2
Device Issue 2
Metal shedding debris 2
Failure to power-up 2
Output above specifications 2
Disassembly 2
Electrical issue 2
Corrosion 2
Device Cleaning Issue 2
Component(s), broken 2
Torn material 2
Foreign material present in device 2
Device-device incompatibility 2
Difficult to advance 2
Dislodged or dislocated 1
Device or device component damaged by another device 1
Incompatibility problem 1
Material Protrusion 1
Output issue 1
Power source issue 1
Mechanics altered 1
Noise, Audible 1
Blank screen 1
Bolus mechanism failure 1
Component falling 1
Component(s), worn 1
Failure to deliver energy 1
Degraded 1
Loose 1
Material frayed 1
Particulates 1
Peeled 1
Failure to run on portable mode 1
Failure to recalibrate 1
Poor quality image 1
Normal 1
Device remains implanted 1
Replace 1
Shaft break 1
Improper or incorrect procedure or method 1
Noise 1
Defective component 1
Other (for use when an appropriate device code cannot be identified) 1
Timer failure 1
Unraveled material 1
Torqued 1
Implant, removal of 1
Residue after decontamination 1
Dissatisfaction 1
Failure to calibrate 1
Failure to align 1
Buckled material 1
Device markings issue 1
Contamination of device ingredient or reagent 1
Total Device Problems 2076

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

-
-