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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device driver, prosthesis
Regulation Description Orthopedic manual surgical instrument.
Product CodeHWR
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 202
Material deformation 95
No code available 17
Crack 10
Fracture 8
Torn material 7
No Known Device Problem 5
Mechanical jam 5
Component missing 5
Material torqued 4
Use of Device Issue 4
Bent 3
Difficult to remove 3
Device operates differently than expected 2
Output issue 1
No Information 1
Defective component 1
Output above specifications 1
Detachment of device component 1
Naturally worn 1
Failure to disconnect 1
Device or device fragments location unknown 1
Detachment of device or device component 1
Total Device Problems 379

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

Recalls
Manufacturer Recall Class Date Posted
1 Biomet Microfixation, Inc. II Apr-11-2010
2 Pioneer Surgical Technology II Nov-27-2007
3 Smith & Nephew, Inc., Endoscopy Div. II Jan-29-2016
4 Wright Medical Technology Inc II Nov-27-2007

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