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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
2016 358 358
2017 1363 1363
2018 681 681
2019 676 676
2020 1462 1462
2021 1085 1085

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 2228 2228
Mechanical Jam 1399 1399
Temperature Problem 374 374
Protective Measures Problem 295 295
Electrical Shorting 152 152
Noise, Audible 131 131
Metal Shedding Debris 131 131
Device Operates Differently Than Expected 125 125
Break 120 120
Flaked 97 97
Device Inoperable 96 96
Mechanical Problem 68 68
Device Displays Incorrect Message 60 60
Electrical /Electronic Property Problem 49 49
Insufficient Information 49 49
Material Fragmentation 42 42
Smoking 41 41
Material Separation 38 38
Sticking 35 35
Physical Resistance/Sticking 35 35
No Apparent Adverse Event 34 34
Communication or Transmission Problem 33 33
Self-Activation or Keying 33 33
Sparking 32 32
Failure to Power Up 30 30
Loss of Power 29 29
Appropriate Term/Code Not Available 29 29
Circuit Failure 27 27
Connection Problem 27 27
Melted 24 24
Detachment Of Device Component 23 23
Unintended Power Up 23 23
Failure to Shut Off 18 18
Thermal Decomposition of Device 15 15
Corroded 15 15
Detachment of Device or Device Component 14 14
Failure to Cut 13 13
Fluid Leak 12 12
Material Disintegration 12 12
Activation Problem 12 12
Device Markings/Labelling Problem 11 11
Device Remains Activated 10 10
Device Stops Intermittently 10 10
Peeled/Delaminated 9 9
Material Deformation 9 9
Device Emits Odor 9 9
Material Twisted/Bent 9 9
Output Problem 8 8
Therapeutic or Diagnostic Output Failure 8 8
Display or Visual Feedback Problem 8 8
Material Integrity Problem 8 8
Defective Component 8 8
Dull, Blunt 8 8
Power Problem 8 8
Partial Blockage 8 8
Image Display Error/Artifact 7 7
Defective Device 7 7
Activation, Positioning or SeparationProblem 7 7
Loose or Intermittent Connection 6 6
Component Falling 6 6
Material Frayed 6 6
Unintended Movement 6 6
Device Contaminated During Manufacture or Shipping 5 5
Positioning Problem 5 5
Device Contamination with Chemical or Other Material 5 5
Failure to Auto Stop 5 5
Component Missing 4 4
Failure to Cycle 4 4
Device Slipped 4 4
Unexpected Shutdown 4 4
Mechanics Altered 4 4
Vibration 4 4
Contamination /Decontamination Problem 4 4
Material Discolored 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Device Fell 3 3
Failure to Advance 3 3
Electronic Property Issue 3 3
Blocked Connection 3 3
Material Protrusion/Extrusion 3 3
Operating System Becomes Nonfunctional 3 3
Intermittent Loss of Power 3 3
Naturally Worn 2 2
Computer Operating System Problem 2 2
Device Dislodged or Dislocated 2 2
Use of Device Problem 2 2
Material Opacification 2 2
Hole In Material 2 2
Unintended Ejection 2 2
Complete Blockage 2 2
Component Incompatible 2 2
Intermittent Energy Output 2 2
Improper or Incorrect Procedure or Method 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2 2
Delivered as Unsterile Product 2 2
Occlusion Within Device 2 2
Energy Output Problem 2 2
Leak/Splash 2 2
Unable to Obtain Readings 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2672 2672
No Clinical Signs, Symptoms or Conditions 1316 1316
No Patient Involvement 977 977
No Information 356 356
No Consequences Or Impact To Patient 223 223
Foreign Body In Patient 28 28
Insufficient Information 17 17
No Code Available 16 16
Burn(s) 13 13
Device Embedded In Tissue or Plaque 11 11
Injury 11 11
Partial thickness (Second Degree) Burn 5 5
Laceration(s) 4 4
Burn, Thermal 3 3
Test Result 3 3
Abrasion 3 3
Patient Problem/Medical Problem 2 2
Not Applicable 1 1
Damage to Ligament(s) 1 1
Pain 1 1
Fever 1 1
Intracranial Hemorrhage 1 1
Failure of Implant 1 1
Muscle Weakness 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
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