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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
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeHWE
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2016 4974 5561
2017 5074 6196
2018 3589 4495
2019 3452 4249
2020 3247 4037
2021 1190 1586

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Jam 2866 2866
Unintended System Motion 2724 2724
Output below Specifications 2185 2185
Fail-Safe Problem 2132 2274
Noise, Audible 1979 1979
Break 1557 1639
Device Operates Differently Than Expected 1526 1532
Overheating of Device 1162 1461
Physical Resistance/Sticking 1135 1289
Fracture 1066 1399
Device Inoperable 990 990
Partial Blockage 751 751
Mechanical Problem 590 592
Detachment of Device or Device Component 528 1017
Naturally Worn 403 403
Complete Loss of Power 372 372
Excessive Heating 350 350
Sticking 301 426
Vibration 299 299
Device Remains Activated 289 1054
Fluid Leak 283 630
Defective Device 275 275
Defective Component 247 247
Leak/Splash 237 413
Unexpected Shutdown 222 222
Detachment Of Device Component 216 221
Intermittent Loss of Power 196 196
Disassembly 188 868
Material Fragmentation 177 193
Intermittent Energy Output 177 177
Device Stops Intermittently 169 169
Air Leak 164 164
Device-Device Incompatibility 156 156
Self-Activation or Keying 152 152
Material Deformation 132 139
Appropriate Term/Code Not Available 129 129
Temperature Problem 125 125
Metal Shedding Debris 112 257
Power Problem 110 110
Difficult To Position 106 106
Incorrect Or Inadequate Test Results 105 105
Protective Measures Problem 104 104
Device Operational Issue 101 101
Failure of Device to Self-Test 100 100
Material Twisted/Bent 99 99
Loose or Intermittent Connection 97 97
Battery Problem 92 93
Corroded 90 90
Failure to Cut 87 87
Loss of Power 83 83
Unintended Power Up 82 135
Material Disintegration 73 162
Crack 69 69
Failure to Power Up 69 69
Bent 68 68
Material Separation 65 65
Dull, Blunt 65 65
Component Missing 58 58
Entrapment of Device 55 55
Unintended Movement 53 53
Failure to Shut Off 51 51
Migration or Expulsion of Device 50 50
Positioning Problem 50 148
Difficult to Remove 48 48
Flaked 47 140
Smoking 46 46
Biocompatibility 41 515
Connection Problem 40 40
Failure to Charge 39 39
Torn Material 39 39
Device Slipped 38 38
Fail-Safe Did Not Operate 38 38
Energy Output Problem 35 35
Electrical /Electronic Property Problem 31 31
Occlusion Within Device 31 31
Adverse Event Without Identified Device or Use Problem 31 31
Charging Problem 31 31
Difficult to Insert 29 29
Difficult to Open or Close 27 135
Retraction Problem 24 24
Fitting Problem 24 24
Material Integrity Problem 24 24
Device Contamination with Chemical or Other Material 23 23
Premature Separation 23 23
Insufficient Information 22 22
Physical Resistance 20 20
Degraded 20 20
Electrical Shorting 20 20
Obstruction of Flow 18 18
Power Conditioning Problem 17 17
Component Falling 17 17
Material Discolored 16 16
Moisture Damage 15 15
Melted 15 15
Device Emits Odor 14 14
Delivered as Unsterile Product 14 87
Device Displays Incorrect Message 13 14
Compatibility Problem 13 13
Mechanics Altered 12 12
Device Reprocessing Problem 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 7741 8961
No Patient Involvement 5708 8633
No Known Impact Or Consequence To Patient 5677 6533
No Clinical Signs, Symptoms or Conditions 1835 2755
No Information 237 303
Foreign Body In Patient 179 179
Device Embedded In Tissue or Plaque 169 169
No Code Available 161 161
Not Applicable 144 144
Burn(s) 75 75
Insufficient Information 49 81
Injury 39 39
Bone Fracture(s) 15 15
Tissue Damage 10 10
Unspecified Infection 8 8
Burn, Thermal 8 8
Pain 7 7
Patient Problem/Medical Problem 7 7
Superficial (First Degree) Burn 7 7
Partial thickness (Second Degree) Burn 6 6
Laceration(s) 6 6
Radiation Exposure, Unintended 5 5
Failure of Implant 5 5
Abrasion 3 3
Therapeutic Effects, Unexpected 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Swelling 2 2
Perforation 2 2
Skin Discoloration 2 3
Skin Irritation 2 2
Death 2 2
Full thickness (Third Degree) Burn 2 2
Alteration In Body Temperature 1 1
Post Operative Wound Infection 1 1
Arrhythmia 1 1
Hemorrhage/Bleeding 1 1
Hyperglycemia 1 1
Damage to Ligament(s) 1 1
Brain Injury 1 1
Complaint, Ill-Defined 1 1
Unspecified Tissue Injury 1 1
Sprain 1 1
Wound Dehiscence 1 1
Hematoma 1 1
Visual Disturbances 1 1
Hip Fracture 1 1
Sedation 1 1
Osteolysis 1 1
Vascular Dissection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Encore Medical, Lp II Jul-27-2019
2 Greatbatch Medical II Jun-01-2016
3 Stryker Instruments Div. of Stryker Corporation II Apr-27-2017
4 Stryker Instruments Div. of Stryker Corporation II Oct-18-2016
5 Synthes (USA) Products LLC II Dec-01-2016
6 Synthes (USA) Products LLC II Jul-12-2016
7 The Anspach Effort, Inc. II Jan-11-2018
8 The Anspach Effort, Inc. I Sep-27-2016
9 Zimmer Biomet, Inc. II Sep-22-2017
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