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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cutter, wire
Regulation Description Orthopedic manual surgical instrument.
Product CodeHXZ
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2021 44 44
2022 37 38
2023 33 33
2024 34 34
2025 33 33
2026 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Break 127 128
Material Integrity Problem 30 30
Fracture 9 9
Crack 8 8
Failure to Cut 6 6
Material Deformation 6 6
Material Twisted/Bent 5 5
Corroded 5 5
Device-Device Incompatibility 4 4
Mechanical Problem 4 4
Device Slipped 3 3
Material Fragmentation 3 3
Activation, Positioning or Separation Problem 2 2
Contamination /Decontamination Problem 2 2
Material Discolored 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Detachment of Device or Device Component 2 2
No Apparent Adverse Event 2 2
Material Frayed 1 1
Compatibility Problem 1 1
Flaked 1 1
Mechanical Jam 1 1
Dull, Blunt 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 172 173
Insufficient Information 18 18
Foreign Body In Patient 5 5
No Consequences Or Impact To Patient 2 2
No Known Impact Or Consequence To Patient 1 1
Oversedation 1 1
Device Embedded In Tissue or Plaque 1 1
Altered State of Consciousness 1 1

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