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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrument, compression
Regulation Description Orthopedic manual surgical instrument.
Product CodeHWN
Regulation Number 888.4540
Device Class 1

Device Problems
Break 52
Crack 10
Device-Device Incompatibility 10
Appropriate Term/Code Not Available 8
Component Missing 7
Material Fragmentation 5
Fracture 4
Naturally Worn 2
Adverse Event Without Identified Device or Use Problem 2
Scratched Material 2
Material Deformation 2
Material Twisted / Bent 2
Flare or Flash 1
Inadequacy of Device Shape and/or Size 1
Fitting Problem 1
Mechanical Jam 1
Failure To Adhere Or Bond 1
Device Reprocessing Problem 1
Device Operates Differently Than Expected 1
Torn Material 1
Insufficient Information 1
Loose or Intermittent Connection 1
Sparking 1
Contamination / decontamination Problem 1
Connection Problem 1
Material Split, Cut or Torn 1
Total Device Problems 120


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