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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device rasp
Regulation Description Manual surgical instrument for general use.
Product CodeHTR
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2021 7 7
2022 15 15
2023 9 9
2024 11 11
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 20 20
Material Integrity Problem 14 14
Break 9 9
Naturally Worn 8 8
Contamination /Decontamination Problem 4 4
Material Fragmentation 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Fracture 2 2
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 43 43
Insufficient Information 5 5
Bone Fracture(s) 1 1
Embolism/Embolus 1 1

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