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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
2014 29 29
2015 24 24
2016 33 33
2017 25 25
2018 26 26
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 198 198
Material Integrity Problem 32 32
Fracture 23 23
Material Fragmentation 15 15
Dull, Blunt 14 14
Failure to Cut 14 14
Material Deformation 8 8
Device Operates Differently Than Expected 8 8
Component Missing 6 6
Mechanical Problem 6 6
Contamination /Decontamination Problem 4 4
Device Inoperable 4 4
Crack 4 4
Naturally Worn 3 3
Detachment of Device or Device Component 3 3
Mechanical Jam 3 3
Device Slipped 3 3
Flaked 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Activation, Positioning or Separation Problem 2 2
Component Falling 1 1
No Apparent Adverse Event 1 1
Delamination 1 1
Expiration Date Error 1 1
Device Expiration Issue 1 1
Defective Device 1 1
Physical Resistance/Sticking 1 1
Device Operational Issue 1 1
Device-Device Incompatibility 1 1
Compatibility Problem 1 1
Material Frayed 1 1
Pressure Problem 1 1
Leak/Splash 1 1
Difficult to Open or Close 1 1
Tip breakage 1 1
Insufficient Information 1 1
Device Fell 1 1
Corroded 1 1
Appropriate Term/Code Not Available 1 1
Bent 1 1
Packaging Problem 1 1
Delivered as Unsterile Product 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 128 128
No Known Impact Or Consequence To Patient 73 73
No Consequences Or Impact To Patient 54 54
No Patient Involvement 52 52
No Code Available 12 12
Insufficient Information 9 9
No Information 8 8
Foreign Body In Patient 8 8
Device Embedded In Tissue or Plaque 2 2
Brain Injury 1 1
Blood Loss 1 1
Alteration In Body Temperature 1 1
Weakness 1 1
Laceration(s) 1 1
Tissue Damage 1 1
Hemorrhage/Bleeding 1 1
Spinal Cord Injury 1 1

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