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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pliers, surgical
Regulation Description Manual surgical instrument for general use.
Product CodeHTC
Regulation Number 878.4800
Device Class 1

Device Problems
Break 81
Material Fragmentation 13
Fitting Problem 9
Device Operates Differently Than Expected 8
Component Missing 7
Detachment of Device or device Component 5
Device-Device Incompatibility 5
Material Twisted / Bent 3
Device Or Device Fragments Location Unknown 3
Bent 2
Fracture 2
Naturally Worn 2
Device Difficult to Maintain 2
Device Dislodged or Dislocated 2
Material Deformation 2
Material Integrity Problem 1
Difficult to Open or Close 1
Insufficient Information 1
Mechanical Jam 1
Dull, Blunt 1
Device Operational Issue 1
Loose or Intermittent Connection 1
Mechanical Problem 1
Material Separation 1
Device Slipped 1
Device Inoperable 1
Device Reprocessing Problem 1
Detachment Of Device Component 1
Component Falling 1
Crack 1
Entrapment of Device 1
Total Device Problems 162

Recalls
Manufacturer Recall Class Date Posted
1 Synthes (USA) Products LLC II Jan-07-2015
2 The Anspach Effort, Inc. II Feb-25-2016
3 The Anspach Effort, Inc. II Feb-03-2016

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