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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bender
Regulation Description Orthopedic manual surgical instrument.
Product CodeHXW
Regulation Number 888.4540
Device Class 1

Device Problems
Fracture 44
Break 20
Device Inoperable 16
Disassembly 15
Detachment of Device or device Component 5
Sticking 4
Mechanical Jam 4
Device Operates Differently Than Expected 4
Device Operational Issue 3
Material Twisted / Bent 2
Naturally Worn 2
Mechanical Problem 1
Defective Device 1
Loose or Intermittent Connection 1
Material Fragmentation 1
Separation Failure 1
Unintended Movement 1
Physical Resistance / Sticking 1
Device Maintenance Issue 1
Migration or Expulsion of Device 1
Pin 1
Component Missing 1
Total Device Problems 130

Recalls
Manufacturer Recall Class Date Posted
1 Synthes, Inc. II Jan-28-2015

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