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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 271
Fracture 143
Unknown (for use when the device problem is not known) 103
Material fragmentation 65
Device, or device fragments remain in patient 51
Tip breakage 18
Device markings issue 17
Device operates differently than expected 12
Failure to align 11
Bent 11
Detachment of device component 7
Metal shedding debris 7
Device, removal of (non-implant) 6
Material integrity issue 6
Other (for use when an appropriate device code cannot be identified) 5
Device handling issue 5
Component(s), broken 5
Mechanical issue 4
No code available 4
Device remains implanted 4
Dull 4
Malfunction 4
Manufacturing or shipping issue associated with device 4
Difficult to remove 3
Shaft break 2
Sticking 2
Crack 2
Delivered as unsterile product 2
Material deformation 2
Device-device incompatibility 2
Difficult to advance 1
No Known Device Problem 1
Operating system becomes non-functional 1
Patient-device incompatibility 1
Detachment of device or device component 1
Unintended collision 1
Unable to obtain readings 1
Device remains activated 1
Difficult to insert 1
Loose 1
Component falling 1
Failure to Adhere or Bond 1
Burrs, breakage of 1
Failure to capture 1
Use of Device Issue 1
Retraction problem 1
Device abrasion from instrument or another object 1
Improper or incorrect procedure or method 1
Motion detector failure 1
Fitting problem 1
Component missing 1
Device contamination with blood or blood product 1
Implant, removal of 1
Device Issue 1
Total Device Problems 806

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

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

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