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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
2017 1363 1363
2018 681 681
2019 676 676
2020 1462 1462
2021 1719 1719
2022 234 234

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 2551 2551
Mechanical Jam 1636 1636
Protective Measures Problem 357 357
Temperature Problem 345 345
Noise, Audible 157 157
Electrical Shorting 152 152
Flaked 127 127
Device Operates Differently Than Expected 99 99
Break 96 96
Mechanical Problem 78 78
Metal Shedding Debris 78 78
Device Inoperable 77 77
Material Fragmentation 61 61
Device Displays Incorrect Message 54 54
Insufficient Information 50 50
Electrical /Electronic Property Problem 49 49
Communication or Transmission Problem 47 47
Physical Resistance/Sticking 45 45
No Apparent Adverse Event 45 45
Material Separation 38 38
Failure to Power Up 37 37
Smoking 35 35
Sticking 34 34
Self-Activation or Keying 33 33
Appropriate Term/Code Not Available 31 31
Connection Problem 30 30
Unintended Power Up 27 27
Circuit Failure 26 26
Sparking 24 24
Loss of Power 23 23
Adverse Event Without Identified Device or Use Problem 23 23
Melted 21 21
Failure to Shut Off 20 20
Detachment of Device or Device Component 20 20
Corroded 16 16
Material Deformation 16 16
Activation Problem 14 14
Failure to Cut 12 12
Thermal Decomposition of Device 12 12
Device Markings/Labelling Problem 11 11
Material Disintegration 11 11
Device Emits Odor 10 10
Material Twisted/Bent 9 9
Device Stops Intermittently 9 9
Peeled/Delaminated 9 9
Dull, Blunt 9 9
Therapeutic or Diagnostic Output Failure 9 9
Fluid Leak 9 9
Display or Visual Feedback Problem 8 8
Output Problem 8 8
Defective Device 8 8
Power Problem 8 8
Defective Component 8 8
Image Display Error/Artifact 7 7
Unexpected Shutdown 7 7
Activation, Positioning or SeparationProblem 7 7
Device Remains Activated 7 7
Loose or Intermittent Connection 6 6
Material Frayed 6 6
Component Missing 6 6
Intermittent Energy Output 6 6
Detachment Of Device Component 6 6
Material Integrity Problem 6 6
Unintended Movement 6 6
Device Contaminated During Manufacture or Shipping 5 5
Material Discolored 5 5
Failure to Auto Stop 5 5
Component Falling 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Positioning Problem 4 4
Contamination /Decontamination Problem 4 4
Partial Blockage 4 4
Leak/Splash 4 4
Vibration 4 4
Failure to Advance 3 3
Electronic Property Issue 3 3
Device-Device Incompatibility 3 3
Device Fell 3 3
Material Protrusion/Extrusion 3 3
Intermittent Loss of Power 3 3
Key or Button Unresponsive/not Working 3 3
Blocked Connection 3 3
Unintended Ejection 3 3
Device Slipped 3 3
Premature Activation 2 2
Crack 2 2
Device Dislodged or Dislocated 2 2
Naturally Worn 2 2
Mechanics Altered 2 2
Activation Failure 2 2
Delivered as Unsterile Product 2 2
Occlusion Within Device 2 2
Unable to Obtain Readings 2 2
Operating System Becomes Nonfunctional 2 2
Material Opacification 2 2
Hole In Material 2 2
Complete Blockage 2 2
Component Incompatible 2 2
Failure to Cycle 2 2
Computer Operating System Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2429 2429
No Clinical Signs, Symptoms or Conditions 2153 2153
No Patient Involvement 941 941
No Information 355 355
No Consequences Or Impact To Patient 159 159
Foreign Body In Patient 30 30
Insufficient Information 24 24
Burn(s) 16 16
No Code Available 12 12
Injury 11 11
Device Embedded In Tissue or Plaque 8 8
Partial thickness (Second Degree) Burn 4 4
Laceration(s) 4 4
Unspecified Infection 3 3
Abrasion 3 3
Test Result 3 3
Burn, Thermal 3 3
Patient Problem/Medical Problem 2 2
Pain 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hemorrhage/Bleeding 2 2
Capsular Contracture 2 2
Eye Injury 1 1
Fever 1 1
Intracranial Hemorrhage 1 1
Failure of Implant 1 1
Adhesion(s) 1 1
Inflammation 1 1
Damage to Ligament(s) 1 1
Muscle Weakness 1 1
Forced Expiratory Volume Decreased 1 1
Post Operative Wound Infection 1 1
Fibrosis 1 1
Blister 1 1
Unspecified Tissue Injury 1 1
Loss of Range of Motion 1 1
Scar Tissue 1 1
Full thickness (Third Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Oct-30-2018
2 Smith & Nephew, Inc. II Feb-22-2017
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