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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
Product CodeHWE
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2019 3452 4249
2020 3248 4035
2021 3140 3843
2022 3327 4019
2023 3399 4241
2024 777 1054

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 3270 3350
Mechanical Jam 2609 2609
Complete Loss of Power 2488 2488
Output below Specifications 1605 1605
Fracture 1525 2128
Excessive Heating 1277 1277
Break 1271 1301
Noise, Audible 954 954
Detachment of Device or Device Component 902 1596
Unintended System Motion 742 742
Appropriate Term/Code Not Available 636 636
Failure to Cut 498 498
Intermittent Loss of Power 475 475
Overheating of Device 408 591
Device-Device Incompatibility 371 371
Fluid/Blood Leak 289 825
Device Remains Activated 220 802
Unexpected Shutdown 175 175
Vibration 161 161
Material Fragmentation 149 234
Material Disintegration 146 374
Leak/Splash 145 145
Material Twisted/Bent 139 139
Intermittent Energy Output 131 131
Naturally Worn 128 128
Device Slipped 115 115
Premature Separation 107 107
Mechanical Problem 106 108
Fail-Safe Problem 103 242
Entrapment of Device 99 99
Fail-Safe Did Not Operate 92 121
Flaked 90 791
Material Deformation 72 73
Crack 68 68
Adverse Event Without Identified Device or Use Problem 67 67
Corroded 56 56
Material Separation 56 56
Defective Device 52 52
Difficult to Open or Close 50 240
Unintended Power Up 40 48
Energy Output Problem 39 39
Unintended Movement 38 38
Dull, Blunt 37 37
Material Integrity Problem 37 37
Compatibility Problem 30 30
Smoking 28 28
Electrical /Electronic Property Problem 27 27
Contamination /Decontamination Problem 23 23
Environmental Particulates 23 23
Difficult or Delayed Separation 21 21
Component Missing 20 20
Difficult to Remove 19 19
Device Emits Odor 19 19
Device Reprocessing Problem 18 18
Material Split, Cut or Torn 17 17
Use of Device Problem 15 15
Connection Problem 15 15
Separation Problem 15 15
Degraded 14 14
No Apparent Adverse Event 13 13
Device Markings/Labelling Problem 13 13
Positioning Failure 13 13
Fitting Problem 12 12
Circuit Failure 12 12
Fire 12 12
Improper or Incorrect Procedure or Method 12 12
Power Problem 11 11
Defective Component 11 11
Device Damaged by Another Device 11 11
Protective Measures Problem 10 10
Loose or Intermittent Connection 10 10
Insufficient Information 10 10
Key or Button Unresponsive/not Working 10 10
Unintended Ejection 9 10
Packaging Problem 9 9
Output Problem 8 8
Difficult to Insert 8 8
Manufacturing, Packaging or Shipping Problem 7 7
Positioning Problem 7 7
Delivered as Unsterile Product 7 50
Tear, Rip or Hole in Device Packaging 7 7
Failure to Cycle 6 6
Scratched Material 6 6
Temperature Problem 6 6
Separation Failure 6 6
Failure to Power Up 5 5
Loosening of Implant Not Related to Bone-Ingrowth 5 5
Display or Visual Feedback Problem 5 5
Communication or Transmission Problem 5 5
Contamination 5 5
Failure to Auto Stop 5 5
Therapeutic or Diagnostic Output Failure 4 4
Device Dislodged or Dislocated 3 3
Activation, Positioning or Separation Problem 3 3
Material Puncture/Hole 3 3
Structural Problem 3 3
Melted 3 3
Explosion 3 3
Sparking 3 3
Failure to Shut Off 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10732 13767
No Consequences Or Impact To Patient 4562 5319
No Known Impact Or Consequence To Patient 905 1301
No Patient Involvement 511 1561
Foreign Body In Patient 353 353
Insufficient Information 292 400
Device Embedded In Tissue or Plaque 112 112
Not Applicable 99 99
No Code Available 91 91
Burn(s) 48 48
No Information 42 106
Injury 31 31
Skin Tears 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Unspecified Tissue Injury 15 15
Bone Fracture(s) 15 15
Superficial (First Degree) Burn 9 9
Pain 8 8
Unspecified Infection 8 8
Failure of Implant 7 7
Laceration(s) 6 6
Tissue Damage 6 6
Abrasion 4 4
Cardiac Perforation 4 4
Burn, Thermal 4 4
Patient Problem/Medical Problem 3 3
Infiltration into Tissue 3 3
Brain Injury 3 3
Full thickness (Third Degree) Burn 2 2
Hemorrhage/Bleeding 2 2
Perforation 2 2
Skin Irritation 2 2
Sprain 1 1
Rupture 1 1
Nerve Damage 1 1
Tinnitus 1 1
Swelling/ Edema 1 1
Damage to Ligament(s) 1 1
Non-union Bone Fracture 1 1
Limb Fracture 1 1
Alteration In Body Temperature 1 1
Skin Discoloration 1 2
Hearing Impairment 1 1
Arrhythmia 1 1
Shock 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Encore Medical, Lp II Jul-27-2019
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