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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
2017 5074 6196
2018 3589 4495
2019 3452 4249
2020 3248 4035
2021 3140 3843
2022 2718 3408

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 2821 2821
Mechanical Jam 2625 2625
Output below Specifications 2281 2281
Physical Resistance/Sticking 2201 2356
Fail-Safe Problem 2097 2248
Noise, Audible 1793 1793
Complete Loss of Power 1424 1424
Fracture 1360 1917
Break 1284 1365
Overheating of Device 976 1193
Excessive Heating 841 841
Detachment of Device or Device Component 775 1403
Device Operates Differently Than Expected 728 729
Device Inoperable 440 440
Intermittent Loss of Power 335 335
Fluid/Blood Leak 327 833
Failure to Cut 317 317
Vibration 289 289
Mechanical Problem 271 273
Device-Device Incompatibility 262 262
Appropriate Term/Code Not Available 261 261
Device Remains Activated 260 1050
Unexpected Shutdown 223 223
Leak/Splash 197 333
Intermittent Energy Output 182 182
Material Fragmentation 163 194
Disassembly 136 641
Material Twisted/Bent 131 131
Device Stops Intermittently 128 128
Detachment Of Device Component 123 123
Material Disintegration 113 267
Difficult To Position 99 99
Device Operational Issue 90 90
Naturally Worn 89 89
Material Deformation 82 89
Entrapment of Device 81 81
Crack 75 75
Flaked 70 373
Dull, Blunt 70 70
Adverse Event Without Identified Device or Use Problem 66 66
Unintended Power Up 65 114
Material Separation 60 60
Premature Separation 60 60
Fail-Safe Did Not Operate 55 55
Difficult to Remove 46 46
Device Slipped 43 43
Unintended Movement 43 43
Difficult to Open or Close 38 187
Energy Output Problem 36 36
Smoking 35 35
Metal Shedding Debris 35 137
Biocompatibility 33 446
Positioning Problem 32 126
Defective Component 30 30
Loose or Intermittent Connection 30 30
Sticking 28 141
Connection Problem 24 24
Compatibility Problem 21 21
Difficult to Insert 21 21
Temperature Problem 21 21
Failure to Power Up 20 20
Corroded 19 19
Contamination /Decontamination Problem 19 19
Fitting Problem 18 18
Electrical /Electronic Property Problem 17 17
Bent 16 16
Material Integrity Problem 16 16
Environmental Particulates 15 15
Delivered as Unsterile Product 14 87
Device Emits Odor 13 13
Difficult or Delayed Separation 13 13
Failure to Charge 12 12
Unintended Ejection 12 15
Device Contamination with Chemical or Other Material 12 12
Degraded 11 11
Insufficient Information 11 11
Protective Measures Problem 10 10
Fire 10 10
Device Reprocessing Problem 10 10
Component Missing 10 10
Defective Device 10 10
No Device Output 9 9
Self-Activation or Keying 8 8
Air Leak 8 8
Output Problem 8 8
Device Markings/Labelling Problem 8 8
No Apparent Adverse Event 8 8
Device Damaged by Another Device 7 7
Electrical Shorting 7 7
Packaging Problem 7 7
No Fail-Safe Mechanism 7 7
Use of Device Problem 7 7
Improper or Incorrect Procedure or Method 6 6
Separation Problem 6 6
Loosening of Implant Not Related to Bone-Ingrowth 5 5
Scratched Material 5 5
Failure to Shut Off 5 5
Failure To Adhere Or Bond 5 5
Circuit Failure 5 5
Contamination 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 7541 8731
No Clinical Signs, Symptoms or Conditions 6233 8147
No Known Impact Or Consequence To Patient 3530 4283
No Patient Involvement 3229 5699
Foreign Body In Patient 295 295
No Information 190 256
Not Applicable 144 144
No Code Available 134 134
Device Embedded In Tissue or Plaque 131 131
Insufficient Information 126 174
Burn(s) 75 75
Injury 39 39
Skin Tears 26 26
Bone Fracture(s) 13 13
Tissue Damage 9 9
Unspecified Tissue Injury 9 9
Superficial (First Degree) Burn 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Burn, Thermal 8 8
Unspecified Infection 8 8
Laceration(s) 8 8
Pain 8 8
Failure of Implant 7 7
Patient Problem/Medical Problem 6 6
Partial thickness (Second Degree) Burn 5 5
Cardiac Perforation 4 4
Abrasion 4 4
Infiltration into Tissue 3 3
Brain Injury 3 3
Radiation Exposure, Unintended 3 3
Full thickness (Third Degree) Burn 2 2
Swelling 2 2
Therapeutic Effects, Unexpected 2 2
Skin Discoloration 2 3
Skin Irritation 2 2
Hemorrhage/Bleeding 2 2
Wound Dehiscence 1 1
Hematoma 1 1
Arrhythmia 1 1
Death 1 1
Sprain 1 1
Perforation 1 1
Damage to Ligament(s) 1 1
Nerve Damage 1 1
Visual Disturbances 1 1
Complaint, Ill-Defined 1 1
Rupture 1 1
Osteolysis 1 1
Alteration In Body Temperature 1 1
Swelling/ Edema 1 1
Limb Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Encore Medical, Lp II Jul-27-2019
2 Stryker Instruments Div. of Stryker Corporation II Apr-27-2017
3 The Anspach Effort, Inc. II Jan-11-2018
4 Zimmer Biomet, Inc. II Sep-22-2017
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