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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 81 180

Device Problems MDRs with this Device Problem Events in those MDRs
Output below Specifications 314 314
Overheating of Device 196 604
Material Puncture/Hole 155 155
Detachment of Device or Device Component 123 148
Fluid/Blood Leak 92 502
No Apparent Adverse Event 74 74
Break 52 50
Unintended System Motion 45 45
Leak/Splash 42 272
Noise, Audible 42 42
Vibration 35 35
Material Twisted/Bent 34 34
Excessive Heating 31 31
Complete Loss of Power 30 30
Physical Resistance/Sticking 28 29
Burst Container or Vessel 27 41
Device Remains Activated 25 25
Fracture 19 19
Electrical /Electronic Property Problem 19 19
Unintended Power Up 15 22
Naturally Worn 14 14
Appropriate Term/Code Not Available 12 12
Mechanical Jam 11 11
Difficult to Insert 11 11
Material Rupture 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Premature Separation 8 8
Difficult to Remove 8 8
Misconnection 7 7
Mechanical Problem 5 5
Material Fragmentation 5 5
Unexpected Shutdown 5 5
Insufficient Information 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 Deformation 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 709 1393
No Consequences Or Impact To Patient 315 541
No Patient Involvement 104 511
No Known Impact Or Consequence To Patient 75 213
Insufficient Information 16 87
Chemical Exposure 13 13
Perforation 12 12
Injury 9 9
Burn(s) 8 8
Device Embedded In Tissue or Plaque 7 7
Unintended Radiation Exposure 7 7
Unspecified Tissue Injury 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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