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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bit, drill
Regulation Description Orthopedic manual surgical instrument.
Product CodeHTW
Regulation Number 888.4540
Device Class 1


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

Device Problems
Break 491
Fracture 171
Material fragmentation 107
Unknown (for use when the device problem is not known) 103
Device, or device fragments remain in patient 51
Bent 51
Device operates differently than expected 21
Tip breakage 18
Failure to align 18
Device markings issue 17
No code available 9
Metal shedding debris 9
Dull 8
Detachment of device component 7
Device, removal of (non-implant) 6
Material integrity issue 6
Device handling issue 5
Other (for use when an appropriate device code cannot be identified) 5
Component(s), broken 5
Mechanical issue 5
Malfunction 4
Manufacturing or shipping issue associated with device 4
Device remains implanted 4
Material deformation 4
Fitting problem 3
Device-device incompatibility 3
Difficult to remove 3
Loss of or failure to bond 3
Use of Device Issue 2
Delivered as unsterile product 2
No Known Device Problem 2
Sticking 2
Shaft break 2
Device Issue 2
Mechanical jam 2
Material erosion 2
Crack 2
Naturally worn 2
Defective item 2
Overheating of device or device component 1
Detachment of device or device component 1
No Information 1
Implant, removal of 1
Difficult to position 1
Burrs, breakage of 1
Loose or intermittent connection 1
Unable to obtain readings 1
Difficult to insert 1
Component falling 1
Difficult to advance 1
Unintended collision 1
Loose 1
Device Contamination with biological material 1
Device remains activated 1
Device abrasion from instrument or another object 1
Retraction problem 1
Component missing 1
Patient-device incompatibility 1
Operating system becomes non-functional 1
Failure to capture 1
Motion detector failure 1
Improper or incorrect procedure or method 1
Device contamination with blood or blood product 1
Failure to Adhere or Bond 1
Total Device Problems 1188

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 1 0 2 1 0 6 5 1 2 2 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II May-26-2016
2 Exactech, Inc. II Sep-11-2012
3 Integra LifeSciences Corp. II Jan-09-2007
4 Intelifuse Inc II Mar-05-2009
5 Interventional Spine Inc II Jan-11-2012
6 Linvatec Corp. dba ConMed Linvatec II Nov-19-2012
7 Orthohelix Surgical Designs Inc II Mar-22-2013
8 Orthohelix Surgical Designs Inc II Apr-22-2010
9 Smith & Nephew Inc II Jun-06-2012
10 Sterilmed Inc II Jan-13-2009
11 Stryker Howmedica Osteonics Corp. II May-01-2013
12 Surgical Instrument Service And Savings, Inc. II Jul-01-2013
13 Synthes (USA) Products LLC II May-23-2016
14 Synthes USA (HQ), Inc. II Jan-11-2012
15 Synthes USA HQ, Inc. II Nov-27-2013
16 Synthes, Inc. II Jun-04-2015
17 The Anspach Effort, Inc. II Jan-11-2014
18 The Anspach Effort, Inc. II Jul-25-2012
19 Trilliant Surgical Ltd. II Aug-24-2015
20 Zimmer, Inc. II May-24-2013

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