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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
2018 26 26
2019 36 36
2020 24 24
2021 44 44
2022 37 37
2023 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Break 96 96
Material Integrity Problem 21 21
Fracture 17 17
Dull, Blunt 11 11
Failure to Cut 11 11
Mechanical Problem 5 5
Material Deformation 5 5
Crack 3 3
Device Operates Differently Than Expected 3 3
Mechanical Jam 3 3
Naturally Worn 3 3
Contamination /Decontamination Problem 2 2
Material Fragmentation 2 2
Material Frayed 1 1
Corroded 1 1
Delivered as Unsterile Product 1 1
Component Missing 1 1
Defective Device 1 1
Detachment of Device or Device Component 1 1
Difficult to Open or Close 1 1
Material Twisted/Bent 1 1
Packaging Problem 1 1
No Apparent Adverse Event 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 89 89
No Consequences Or Impact To Patient 38 38
No Patient Involvement 19 19
No Known Impact Or Consequence To Patient 15 15
No Code Available 7 7
No Information 3 3
Insufficient Information 2 2
Foreign Body In Patient 2 2
Tissue Damage 1 1
Brain Injury 1 1
Spinal Cord Injury 1 1
Alteration In Body Temperature 1 1
Laceration(s) 1 1
Weakness 1 1
Blood Loss 1 1
Device Embedded In Tissue or Plaque 1 1
Hemorrhage/Bleeding 1 1

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