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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 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Break 123 124
Material Integrity Problem 30 30
Fracture 9 9
Crack 6 6
Failure to Cut 6 6
Material Twisted/Bent 5 5
Material Deformation 5 5
Corroded 5 5
Mechanical Problem 4 4
Material Fragmentation 4 4
Device Slipped 3 3
Activation, Positioning or Separation Problem 2 2
Device-Device Incompatibility 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 168 169
Insufficient Information 16 16
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

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