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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device saw, powered, and accessories
Product CodeHAB
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2018 681 681
2019 676 676
2020 1462 1462
2021 1719 1719
2022 387 387

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 1962 1962
Mechanical Jam 1628 1628
Protective Measures Problem 357 357
Flaked 128 128
Noise, Audible 112 112
Break 84 84
Mechanical Problem 79 79
Temperature Problem 74 74
Material Fragmentation 66 66
Electrical Shorting 63 63
No Apparent Adverse Event 49 49
Insufficient Information 49 49
Physical Resistance/Sticking 48 48
Communication or Transmission Problem 47 47
Material Separation 38 38
Electrical /Electronic Property Problem 33 33
Appropriate Term/Code Not Available 30 30
Connection Problem 29 29
Unintended Power Up 28 28
Failure to Power Up 28 28
Device Inoperable 26 26
Adverse Event Without Identified Device or Use Problem 25 25
Self-Activation or Keying 24 24
Smoking 23 23
Device Displays Incorrect Message 23 23
Device Operates Differently Than Expected 22 22
Detachment of Device or Device Component 19 19
Material Deformation 19 19
Corroded 15 15
Melted 14 14
Metal Shedding Debris 14 14
Activation Problem 14 14
Failure to Cut 12 12
Loss of Power 12 12
Circuit Failure 11 11
Device Markings/Labelling Problem 11 11
Sparking 9 9
Material Twisted/Bent 9 9
Failure to Shut Off 9 9
Therapeutic or Diagnostic Output Failure 9 9
Thermal Decomposition of Device 9 9
Material Disintegration 9 9
Display or Visual Feedback Problem 8 8
Sticking 8 8
Defective Component 8 8
Dull, Blunt 8 8
Output Problem 8 8
Power Problem 8 8
Key or Button Unresponsive/not Working 8 8
Defective Device 8 8
Activation, Positioning or Separation Problem 7 7
Unexpected Shutdown 7 7
Intermittent Energy Output 7 7
Device Emits Odor 7 7
Fluid/Blood Leak 7 7
Material Frayed 6 6
Image Display Error/Artifact 6 6
Device Remains Activated 6 6
Material Integrity Problem 6 6
Device Contaminated During Manufacture or Shipping 5 5
Peeled/Delaminated 5 5
Material Discolored 5 5
Detachment Of Device Component 4 4
Unintended Ejection 4 4
Component Missing 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Failure to Auto Stop 4 4
Contamination /Decontamination Problem 4 4
Positioning Problem 4 4
Unintended Movement 4 4
Device Fell 3 3
Intermittent Loss of Power 3 3
Blocked Connection 3 3
Device-Device Incompatibility 3 3
Device Stops Intermittently 3 3
Partial Blockage 3 3
Leak/Splash 3 3
Loose or Intermittent Connection 3 3
Component Falling 3 3
Component Incompatible 2 2
Complete Blockage 2 2
Crack 2 2
Material Opacification 2 2
Energy Output Problem 2 2
Delivered as Unsterile Product 2 2
Premature Activation 2 2
Improper or Incorrect Procedure or Method 2 2
Vibration 2 2
Device Dislodged or Dislocated 2 2
Output below Specifications 2 2
Activation Failure 2 2
Complete Loss of Power 1 1
Firing Problem 1 1
Scratched Material 1 1
Packaging Problem 1 1
Unintended Electrical Shock 1 1
Separation Problem 1 1
Unclear Information 1 1
Excessive Heating 1 1
Application Program Freezes, Becomes Nonfunctional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2306 2306
No Known Impact Or Consequence To Patient 1390 1390
No Patient Involvement 906 906
No Information 184 184
No Consequences Or Impact To Patient 57 57
Foreign Body In Patient 27 27
Insufficient Information 25 25
Burn(s) 14 14
Injury 10 10
No Code Available 7 7
Device Embedded In Tissue or Plaque 6 6
Burn, Thermal 3 3
Unspecified Infection 3 3
Laceration(s) 3 3
Partial thickness (Second Degree) Burn 3 3
Pain 2 2
Capsular Contracture 2 2
Patient Problem/Medical Problem 2 2
Hemorrhage/Bleeding 2 2
Loss of Range of Motion 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Abrasion 2 2
Hematoma 1 1
Intracranial Hemorrhage 1 1
Inflammation 1 1
Unspecified Tissue Injury 1 1
Eye Injury 1 1
Forced Expiratory Volume Decreased 1 1
Post Operative Wound Infection 1 1
Scar Tissue 1 1
Adhesion(s) 1 1
Test Result 1 1
Full thickness (Third Degree) Burn 1 1
Fibrosis 1 1
Blister 1 1
Metal Related Pathology 1 1
Rupture 1 1
Muscle Weakness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Oct-30-2018
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