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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device motor, drill, electric
Product CodeHBC
Regulation Number 882.4360
Device Class 2


Premarket Reviews
ManufacturerDecision
BIEN-AIR SURGERY SA
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC POWERED SURGICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 3
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZETHON LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2079 2079
2018 1779 1779
2019 1703 1703
2020 1304 1304
2021 946 946
2022 291 291

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 2714 2714
Vibration 1450 1450
Excessive Heating 1332 1332
Unintended System Motion 726 726
Detachment of Device or Device Component 437 437
Material Twisted/Bent 309 309
Bent 280 280
Fail-Safe Problem 268 268
Device Damaged by Another Device 252 252
Device Alarm System 228 228
Detachment Of Device Component 215 215
Noise, Audible 142 142
Device Displays Incorrect Message 132 132
Device Operates Differently Than Expected 120 120
Complete Loss of Power 117 117
Fracture 112 112
Break 97 97
Fail-Safe Did Not Operate 95 95
Device-Device Incompatibility 86 86
Material Fragmentation 74 74
Mechanical Problem 68 68
Device Inoperable 53 53
Difficult To Position 49 49
Mechanical Jam 43 43
Output below Specifications 42 42
Fluid Leak 39 39
Leak/Splash 37 37
Difficult to Remove 33 33
Material Frayed 31 31
Separation Problem 26 26
Defective Component 22 22
Premature Separation 21 21
Material Deformation 20 20
Material Separation 19 19
Appropriate Term/Code Not Available 17 17
Cut In Material 16 16
Device Operational Issue 16 16
Smoking 15 15
Device Reprocessing Problem 14 14
Device Stops Intermittently 13 13
Naturally Worn 11 11
Adverse Event Without Identified Device or Use Problem 11 11
Difficult to Insert 10 10
Material Rupture 10 10
Device Slipped 9 9
Dull, Blunt 8 8
Electrical /Electronic Property Problem 8 8
Unintended Movement 8 8
Corroded 7 7
Loose or Intermittent Connection 7 7
Connection Problem 7 7
Difficult or Delayed Separation 7 7
Component Missing 6 6
Image Display Error/Artifact 6 6
Intermittent Loss of Power 5 5
Environmental Particulates 4 4
Device Remains Activated 4 4
Self-Activation or Keying 4 4
Contamination /Decontamination Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Defective Device 3 3
Torn Material 3 3
No Apparent Adverse Event 3 3
Metal Shedding Debris 3 3
Retraction Problem 3 3
Premature Activation 3 3
Air Leak 3 3
Component or Accessory Incompatibility 3 3
Separation Failure 3 3
Contamination 3 3
Misconnection 3 3
Power Problem 3 3
Device Fell 3 3
Physical Resistance/Sticking 2 2
Loss of Power 2 2
Display or Visual Feedback Problem 2 2
Intermittent Energy Output 2 2
No Fail-Safe Mechanism 2 2
Moisture or Humidity Problem 2 2
Disconnection 2 2
Circuit Failure 1 1
Component Falling 1 1
Intermittent Continuity 1 1
Output above Specifications 1 1
Device Markings/Labelling Problem 1 1
Positioning Problem 1 1
Component Misassembled 1 1
Packaging Problem 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Difficult to Open or Remove Packaging Material 1 1
Failure to Auto Stop 1 1
Activation Problem 1 1
Crack 1 1
Degraded 1 1
Material Puncture/Hole 1 1
Particulates 1 1
Use of Device Problem 1 1
Structural Problem 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 3766 3766
No Known Impact Or Consequence To Patient 1749 1749
No Clinical Signs, Symptoms or Conditions 1365 1365
No Patient Involvement 1146 1146
Burn(s) 22 22
Patient Problem/Medical Problem 14 14
Insufficient Information 13 13
Foreign Body In Patient 13 13
Brain Injury 9 9
Nervous System Injury 8 8
Tissue Damage 6 6
Burn, Thermal 5 5
Death 5 5
Not Applicable 5 5
No Code Available 4 4
Injury 3 3
Failure of Implant 2 2
Perforation 2 2
Blood Loss 2 2
Superficial (First Degree) Burn 2 2
Unspecified Tissue Injury 2 2
No Information 2 2
Full thickness (Third Degree) Burn 2 2
Device Embedded In Tissue or Plaque 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Electric Shock 1 1
Chemical Exposure 1 1
Aneurysm 1 1
Skull Fracture 1 1
Peroneal Nerve Palsy 1 1
Post Traumatic Wound Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 The Anspach Effort, Inc. II May-04-2017
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