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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device clamp
Regulation Description Manual surgical instrument for general use.
Product CodeHXD
Regulation Number 878.4800
Device Class 1

Device Problems
Break 108
Appropriate Term/Code Not Available 103
Device-Device Incompatibility 51
Mechanical Jam 21
Component Missing 16
Mechanical Problem 14
Fracture 12
Naturally Worn 11
Physical Resistance / Sticking 9
Connection Problem 8
Disassembly 6
Loose or Intermittent Connection 6
Material Deformation 5
Fitting Problem 5
Device Issue 4
Device Operates Differently Than Expected 4
Material Twisted / Bent 4
Difficult to Remove 3
Bent 3
Product Quality Problem 3
Difficult to Open or Close 3
Separation Problem 3
Crack 3
Defective Device 3
Insufficient Information 2
Dull, Blunt 2
Entrapment of Device 2
Difficult to Insert 2
Adverse Event Without Identified Device or Use Problem 2
Failure to Calibrate 1
Defective Component 1
Material Integrity Problem 1
Material Disintegration 1
Device Markings / Labelling Problem 1
Material Distortion 1
Positioning Problem 1
Blocked Connection 1
Failure to Discharge 1
Difficult To Position 1
Device Slipped 1
Failure to Align 1
Locking Mechanism 1
Clamp 1
Material Fragmentation 1
Material Separation 1
Unintended Movement 1
Incomplete or Inadequate Connection 1
Total Device Problems 436

Recalls
Manufacturer Recall Class Date Posted
1 Stryker GmbH II Jun-15-2018
2 Symmetry Surgical, Inc. II Jul-30-2015

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