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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 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Break 109 109
Material Integrity Problem 31 31
Failure to Cut 13 13
Fracture 12 12
Dull, Blunt 10 10
Material Deformation 7 7
Mechanical Problem 5 5
Crack 3 3
Contamination /Decontamination Problem 3 3
Material Fragmentation 3 3
Naturally Worn 3 3
Device Slipped 2 2
Activation, Positioning or Separation Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Detachment of Device or Device Component 2 2
Material Frayed 1 1
Device-Device Incompatibility 1 1
Compatibility Problem 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Defective Device 1 1
Component Missing 1 1
Material Twisted/Bent 1 1
Packaging Problem 1 1
No Apparent Adverse Event 1 1
Difficult to Open or Close 1 1
Corroded 1 1
Flaked 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 128 128
No Consequences Or Impact To Patient 28 28
No Patient Involvement 15 15
No Known Impact Or Consequence To Patient 9 9
Insufficient Information 9 9
Foreign Body In Patient 5 5
No Code Available 3 3
No Information 3 3
Laceration(s) 1 1
Tissue Damage 1 1
Hemorrhage/Bleeding 1 1

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