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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
2015 485 485
2016 358 358
2017 1363 1363
2018 681 681
2019 676 676
2020 1104 1104

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 2092 2092
Mechanical Jam 578 578
Metal Shedding Debris 394 394
Temperature Problem 385 385
Handpiece 164 164
Device Operates Differently Than Expected 153 153
Electrical Shorting 151 151
Break 135 135
Noise, Audible 119 119
Knife 112 112
Device Inoperable 108 108
Switch, Push Button 68 68
Flaked 60 60
Device Displays Incorrect Message 58 58
Mechanical Problem 57 57
Electrical /Electronic Property Problem 54 54
Smoking 52 52
Insufficient Information 47 47
Material Fragmentation 44 44
Sparking 43 43
Motor(s) 41 41
Self-Activation or Keying 41 41
Sticking 38 38
Material Separation 34 34
Loss of Power 31 31
Melted 30 30
Detachment Of Device Component 30 30
Appropriate Term/Code Not Available 29 29
Protective Measures Problem 28 28
Circuit Failure 28 28
Cord 26 26
Physical Resistance/Sticking 21 21
Failure to Shut Off 19 19
Tip 18 18
Thermal Decomposition of Device 18 18
Fluid Leak 16 16
Failure to Power Up 15 15
Cable, Electrical 15 15
Material Disintegration 15 15
Failure to Cut 15 15
Unintended Power Up 15 15
Connection Problem 15 15
Device Contamination with Chemical or Other Material 15 15
Detachment of Device or Device Component 14 14
Device Markings/Labelling Problem 11 11
Dull, Blunt 11 11
Device Remains Activated 10 10
Device Stops Intermittently 10 10
Partial Blockage 10 10
Material Integrity Problem 10 10
Device Emits Odor 10 10
Communication or Transmission Problem 9 9
Peeled/Delaminated 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Power Problem 7 7
Image Display Error/Artifact 7 7
Loose or Intermittent Connection 7 7
Defective Component 7 7
Component Falling 7 7
Activation, Positioning or SeparationProblem 7 7
Material Twisted/Bent 7 7
Device Slipped 7 7
Display or Visual Feedback Problem 7 7
Therapeutic or Diagnostic Output Failure 7 7
Defective Device 6 6
Naturally Worn 6 6
Corroded 6 6
Material Frayed 6 6
Pin 6 6
Unintended Movement 6 6
Positioning Problem 6 6
Shaft 5 5
Battery 5 5
Material Discolored 5 5
Particulates 5 5
Difficult to Remove 5 5
Activation Problem 5 5
Failure to Cycle 4 4
Output Problem 4 4
Failure to Auto Stop 4 4
Contamination /Decontamination Problem 4 4
Leak/Splash 4 4
Vibration 4 4
Mechanics Altered 4 4
Unit 4 4
Device Fell 3 3
Failure to Advance 3 3
Electronic Property Issue 3 3
Power Cord 3 3
Material Protrusion/Extrusion 3 3
Operating System Becomes Nonfunctional 3 3
Blocked Connection 3 3
Use of Device Problem 3 3
Component Missing 3 3
Unintended Ejection 3 3
Hole In Material 3 3
No Apparent Adverse Event 3 3
Intermittent Loss of Power 3 3
Bent 2 2
Material Opacification 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2952 2952
No Patient Involvement 922 922
No Information 346 346
No Consequences Or Impact To Patient 322 322
Foreign Body In Patient 32 32
Device Embedded In Tissue or Plaque 21 21
No Code Available 20 20
Burn(s) 18 18
Injury 11 11
Abrasion 6 6
Partial thickness (Second Degree) Burn 5 5
Laceration(s) 5 5
Burn, Thermal 4 4
Test Result 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Complaint, Ill-Defined 2 2
Patient Problem/Medical Problem 2 2
Cardiac Arrest 2 2
Death 2 2
Edema 1 1
Not Applicable 1 1
Electric Shock 1 1
Vascular System (Circulation), Impaired 1 1
Damage to Ligament(s) 1 1
Pain 1 1
Shock 1 1
Insufficient Information 1 1
Fluid Discharge 1 1
Fever 1 1
Intracranial Hemorrhage 1 1
Failure of Implant 1 1
Muscle Weakness 1 1
Therapeutic Effects, Unexpected 1 1
Perforation of Vessels 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Oct-30-2018
2 Smith & Nephew, Inc. II Feb-22-2017
3 Zimmer Biomet, Inc. II Oct-26-2016
4 Zimmer, Inc. II Dec-21-2015
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