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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
2020 24 24
2021 44 44
2022 37 37
2023 33 33
2024 34 34
2025 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Break 127 127
Material Integrity Problem 31 31
Fracture 13 13
Failure to Cut 7 7
Mechanical Problem 5 5
Crack 5 5
Material Deformation 5 5
Device Slipped 3 3
Contamination /Decontamination Problem 3 3
Material Fragmentation 3 3
Material Twisted/Bent 3 3
Activation, Positioning or Separation Problem 2 2
Device-Device Incompatibility 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Detachment of Device or Device Component 2 2
Material Frayed 1 1
Compatibility Problem 1 1
Device Fell 1 1
No Apparent Adverse Event 1 1
Naturally Worn 1 1
Corroded 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 159 159
No Consequences Or Impact To Patient 16 16
Insufficient Information 15 15
Foreign Body In Patient 6 6
No Known Impact Or Consequence To Patient 3 3
No Patient Involvement 3 3
No Code Available 1 1
Oversedation 1 1
Tissue Damage 1 1
Hemorrhage/Bleeding 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer Biomet, Inc. II Dec-22-2020
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