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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 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Break 189 189
Material Integrity Problem 30 30
Fracture 22 22
Material Fragmentation 15 15
Dull, Blunt 14 14
Failure to Cut 14 14
Device Operates Differently Than Expected 8 8
Material Deformation 7 7
Mechanical Problem 6 6
Component Missing 6 6
Device Inoperable 4 4
Crack 4 4
Contamination /Decontamination Problem 4 4
Mechanical Jam 3 3
Naturally Worn 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Activation, Positioning or Separation Problem 2 2
Detachment of Device or Device Component 2 2
Device Slipped 2 2
Flaked 2 2
Bent 1 1
Delivered as Unsterile Product 1 1
Tip breakage 1 1
Device Expiration Issue 1 1
Component Falling 1 1
Corroded 1 1
Material Frayed 1 1
Leak/Splash 1 1
Delamination 1 1
Defective Device 1 1
Expiration Date Error 1 1
Packaging Problem 1 1
Pressure Problem 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Material Twisted/Bent 1 1
Device Operational Issue 1 1
Device-Device Incompatibility 1 1
Difficult to Open or Close 1 1
Compatibility Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 119 119
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
Foreign Body In Patient 8 8
No Information 8 8
Insufficient Information 6 6
Device Embedded In Tissue or Plaque 2 2
Alteration In Body Temperature 1 1
Brain Injury 1 1
Spinal Cord Injury 1 1
Blood Loss 1 1
Hemorrhage/Bleeding 1 1
Laceration(s) 1 1
Tissue Damage 1 1
Weakness 1 1

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