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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeHWE
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2020 3248 4035
2021 3140 3843
2022 3327 4019
2023 3398 4240
2024 3690 4957
2025 1338 1913

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 4096 4102
Complete Loss of Power 3176 3176
Mechanical Jam 2719 2719
Excessive Heating 1530 1530
Break 1445 1451
Fracture 1416 2057
Output below Specifications 1004 1004
Appropriate Term/Code Not Available 992 992
Detachment of Device or Device Component 941 1692
Noise, Audible 800 800
Failure to Cut 650 650
Unintended System Motion 622 623
Intermittent Loss of Power 585 585
Device-Device Incompatibility 469 469
Overheating of Device 299 452
Mechanical Problem 259 260
Fluid/Blood Leak 252 781
Device Remains Activated 223 692
Material Fragmentation 189 273
Device Slipped 180 180
Naturally Worn 179 179
Material Twisted/Bent 177 177
Leak/Splash 174 174
Material Disintegration 171 488
Vibration 146 146
Premature Separation 137 137
Material Deformation 131 131
Fail-Safe Did Not Operate 126 377
Flaked 115 1506
Entrapment of Device 108 108
Electrical /Electronic Property Problem 89 89
Fail-Safe Problem 87 191
Corroded 80 81
Defective Device 70 70
Adverse Event Without Identified Device or Use Problem 64 64
Difficult to Open or Close 59 211
Crack 45 45
Energy Output Problem 45 45
Unintended Movement 44 45
Material Integrity Problem 42 42
Compatibility Problem 38 38
Dull, Blunt 35 35
Material Separation 31 31
Unintended Power Up 31 37
Environmental Particulates 30 30
Material Split, Cut or Torn 30 30
Component Missing 29 29
Contamination /Decontamination Problem 29 29
Smoking 27 27
Device Reprocessing Problem 27 27

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14644 19199
No Consequences Or Impact To Patient 2274 2605
Insufficient Information 627 807
Foreign Body In Patient 353 354
No Patient Involvement 236 799
No Known Impact Or Consequence To Patient 153 254
Device Embedded In Tissue or Plaque 99 99
No Code Available 66 66
Burn(s) 41 41
Skin Tears 26 26
Injury 26 26
Not Applicable 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Unspecified Tissue Injury 18 18
No Information 15 28
Bone Fracture(s) 14 14
Superficial (First Degree) Burn 10 10
Unspecified Infection 6 6
Failure of Implant 6 6
Pain 5 5
Laceration(s) 4 4
Cardiac Perforation 4 4
Burn, Thermal 4 4
Abrasion 4 4
Brain Injury 3 3
Infiltration into Tissue 3 3
Full thickness (Third Degree) Burn 3 3
Perforation 2 2
Limb Fracture 2 2
Tissue Damage 2 2
Hemorrhage/Bleeding 2 2
Skin Discoloration 1 2
Rupture 1 1
Nerve Damage 1 1
Hypersensitivity/Allergic reaction 1 1
Shock 1 1
Non-union Bone Fracture 1 1
Swelling/ Edema 1 1
Arrhythmia 1 1
Patient Problem/Medical Problem 1 1
Tinnitus 1 1
Hearing Impairment 1 1

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