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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
Regulation Description Surgical instrument motors and accessories/attachments.
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 1718 1718

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 2353 2353
Mechanical Jam 1617 1617
Protective Measures Problem 356 356
Temperature Problem 345 345
Electrical Shorting 150 150
Noise, Audible 134 134
Flaked 119 119
Device Operates Differently Than Expected 99 99
Break 86 86
Metal Shedding Debris 78 78
Device Inoperable 77 77
Mechanical Problem 72 72
Material Fragmentation 57 57
Device Displays Incorrect Message 54 54
Insufficient Information 49 49
Electrical /Electronic Property Problem 46 46
Physical Resistance/Sticking 45 45
Communication or Transmission Problem 43 43
No Apparent Adverse Event 40 40
Material Separation 38 38
Failure to Power Up 36 36
Smoking 35 35
Sticking 34 34
Appropriate Term/Code Not Available 31 31
Connection Problem 30 30
Self-Activation or Keying 30 30
Circuit Failure 26 26
Unintended Power Up 26 26
Sparking 24 24
Adverse Event Without Identified Device or Use Problem 23 23
Loss of Power 23 23
Melted 21 21
Detachment of Device or Device Component 18 18
Failure to Shut Off 18 18
Corroded 16 16
Material Deformation 13 13
Activation Problem 13 13
Failure to Cut 12 12
Thermal Decomposition of Device 12 12
Material Disintegration 11 11
Device Markings/Labelling Problem 11 11
Dull, Blunt 9 9
Material Twisted/Bent 9 9
Therapeutic or Diagnostic Output Failure 9 9
Fluid Leak 9 9
Device Stops Intermittently 9 9
Peeled/Delaminated 9 9
Defective Component 8 8
Display or Visual Feedback Problem 8 8
Output Problem 8 8
Power Problem 8 8
Defective Device 8 8
Activation, Positioning or SeparationProblem 7 7
Image Display Error/Artifact 7 7
Device Remains Activated 7 7
Device Emits Odor 6 6
Loose or Intermittent Connection 6 6
Component Missing 6 6
Material Frayed 6 6
Detachment Of Device Component 6 6
Unintended Movement 6 6
Material Integrity Problem 6 6
Device Contaminated During Manufacture or Shipping 5 5
Failure to Auto Stop 5 5
Material Discolored 5 5
Component Falling 4 4
Partial Blockage 4 4
Contamination /Decontamination Problem 4 4
Vibration 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Positioning Problem 4 4
Unexpected Shutdown 4 4
Intermittent Energy Output 4 4
Device Fell 3 3
Material Protrusion/Extrusion 3 3
Blocked Connection 3 3
Failure to Advance 3 3
Electronic Property Issue 3 3
Device-Device Incompatibility 3 3
Leak/Splash 3 3
Unintended Ejection 3 3
Device Slipped 3 3
Intermittent Loss of Power 3 3
Unable to Obtain Readings 2 2
Improper or Incorrect Procedure or Method 2 2
Hole In Material 2 2
Delivered as Unsterile Product 2 2
Occlusion Within Device 2 2
Material Opacification 2 2
Energy Output Problem 2 2
Premature Activation 2 2
Component Incompatible 2 2
Complete Blockage 2 2
Crack 2 2
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2 2
Failure to Cycle 2 2
Device Dislodged or Dislocated 2 2
Device Contamination with Chemical or Other Material 2 2
Computer Operating System Problem 2 2
Naturally Worn 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 1920 1920
No Patient Involvement 941 941
No Information 355 355
No Consequences Or Impact To Patient 159 159
Foreign Body In Patient 29 29
Insufficient Information 23 23
Burn(s) 15 15
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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Patient Problem/Medical Problem 2 2
Pain 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
Loss of Range of Motion 1 1
Scar Tissue 1 1
Fibrosis 1 1
Unspecified Tissue Injury 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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