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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cutter, wire
Product CodeHXZ
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2019 36 36
2020 24 24
2021 44 44
2022 37 37
2023 33 33
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Break 100 100
Material Integrity Problem 29 29
Failure to Cut 13 13
Fracture 11 11
Dull, Blunt 10 10
Material Deformation 6 6
Mechanical Problem 5 5
Crack 3 3
Naturally Worn 3 3
Material Fragmentation 3 3
Contamination /Decontamination Problem 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Activation, Positioning or Separation Problem 2 2
No Apparent Adverse Event 1 1
Difficult to Open or Close 1 1
Component Missing 1 1
Material Frayed 1 1
Material Twisted/Bent 1 1
Device Fell 1 1
Compatibility Problem 1 1
Corroded 1 1
Mechanical Jam 1 1
Device-Device Incompatibility 1 1
Physical Resistance/Sticking 1 1
Defective Device 1 1
Device Slipped 1 1
Packaging Problem 1 1
Detachment of Device or Device Component 1 1
Flaked 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 119 119
No Consequences Or Impact To Patient 28 28
No Patient Involvement 15 15
No Known Impact Or Consequence To Patient 9 9
Insufficient Information 6 6
Foreign Body In Patient 5 5
No Information 3 3
No Code Available 3 3
Hemorrhage/Bleeding 1 1
Laceration(s) 1 1
Tissue Damage 1 1

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