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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device motor, drill, pneumatic
Product CodeHBB
Regulation Number 882.4370
Device Class 2

MDR Year MDR Reports MDR Events
2019 284 722
2020 263 372
2021 260 419
2022 172 332
2023 180 306
2024 24 70

Device Problems MDRs with this Device Problem Events in those MDRs
Output below Specifications 313 313
Overheating of Device 177 555
Material Puncture/Hole 146 146
Detachment of Device or Device Component 118 141
Fluid/Blood Leak 88 477
No Apparent Adverse Event 69 69
Break 47 45
Unintended System Motion 44 44
Leak/Splash 41 271
Noise, Audible 41 41
Vibration 35 35
Excessive Heating 30 30
Physical Resistance/Sticking 28 29
Complete Loss of Power 27 27
Material Twisted/Bent 27 27
Burst Container or Vessel 27 41
Device Remains Activated 25 25
Fracture 18 18
Electrical /Electronic Property Problem 18 18
Unintended Power Up 15 22
Naturally Worn 13 13
Appropriate Term/Code Not Available 12 12
Difficult to Insert 11 11
Material Rupture 11 11
Mechanical Jam 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Difficult to Remove 8 8
Misconnection 6 6
Mechanical Problem 5 5
Material Fragmentation 5 5
Insufficient Information 5 5
Premature Separation 5 5
Unexpected Shutdown 5 5
Intermittent Loss of Power 4 4
Gas/Air Leak 4 4
Energy Output Problem 4 4
Fail-Safe Problem 4 9
Failure to Auto Stop 3 3
Device-Device Incompatibility 3 3
Loss of Power 3 3
Degraded 3 3
Fail-Safe Did Not Operate 3 3
Smoking 2 2
Device Slipped 1 1
Device Damaged by Another Device 1 1
Defective Component 1 1
Component Missing 1 1
Dull, Blunt 1 1
Structural Problem 1 1
Loose or Intermittent Connection 1 1
Entrapment of Device 1 1
Material Discolored 1 1
No Display/Image 1 1
Device Reprocessing Problem 1 1
Intermittent Energy Output 1 1
Separation Problem 1 1
Difficult or Delayed Separation 1 1
Material Integrity Problem 1 1
Positioning Problem 1 1
Unintended Movement 1 1
Device Fell 1 1
Explosion 1 1
Ejection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 653 1284
No Consequences Or Impact To Patient 315 541
No Patient Involvement 104 511
No Known Impact Or Consequence To Patient 75 213
Insufficient Information 15 58
Chemical Exposure 13 13
Perforation 12 12
Injury 9 9
Burn(s) 8 8
Device Embedded In Tissue or Plaque 7 7
Unspecified Tissue Injury 6 6
Unintended Radiation Exposure 6 6
Cerebrospinal Fluid Leakage 6 6
Hearing Impairment 6 6
Hemorrhage/Bleeding 5 5
Unspecified Infection 5 5
Tissue Damage 5 5
Foreign Body In Patient 4 4
Nerve Damage 4 4
Spinal Column Injury 4 4
Tinnitus 3 3
Death 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Information 2 55
Spinal Cord Injury 2 2
Pain 2 2
Acoustic Trauma 1 2
Oversedation 1 1
Laceration(s) 1 1
Muscle Weakness 1 1
Fatigue 1 1
Headache 1 1
Contusion 1 1
Intracranial Hemorrhage 1 1
Failure of Implant 1 1
Hematoma 1 1
Reaction 1 1
Numbness 1 1
No Code Available 1 1
Partial thickness (Second Degree) Burn 1 3
Radiation Exposure, Unintended 1 1

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