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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
Regulation Description Electric cranial drill motor.
Product CodeHBC
Regulation Number 882.4360
Device Class 2


Premarket Reviews
ManufacturerDecision
BIEN-AIR SURGERY SA
  SUBSTANTIALLY EQUIVALENT 1
SAESHIN PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZETHON LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1304 1304
2021 946 946
2022 760 760
2023 664 664
2024 427 427
2025 270 270

Device Problems MDRs with this Device Problem Events in those MDRs
Excessive Heating 1924 1924
Vibration 602 602
Overheating of Device 478 478
Device Damaged by Another Device 438 438
Detachment of Device or Device Component 301 301
Complete Loss of Power 264 264
Unintended System Motion 253 253
Device Alarm System 203 203
Noise, Audible 187 187
Break 165 165
Device-Device Incompatibility 151 151
Fail-Safe Did Not Operate 129 129
Appropriate Term/Code Not Available 114 114
Material Fragmentation 110 110
Mechanical Jam 59 59
Material Frayed 49 49
Separation Problem 46 46
Leak/Splash 41 41
Output below Specifications 38 38
Difficult or Delayed Separation 35 35
Fail-Safe Problem 34 34
Premature Separation 31 31
No Apparent Adverse Event 26 26
Device Slipped 24 24
Mechanical Problem 23 23
Loss of Power 18 18
Environmental Particulates 16 16
Electrical /Electronic Property Problem 14 14
Corroded 14 14
Device Reprocessing Problem 14 14
Difficult to Insert 12 12
Fluid/Blood Leak 11 11
Component Missing 10 10
Intermittent Loss of Power 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Device Remains Activated 7 7
Dull, Blunt 7 7
Physical Resistance/Sticking 7 7
Device Markings/Labelling Problem 7 7
Difficult to Remove 6 6
Device Displays Incorrect Message 6 6
Naturally Worn 6 6
Connection Problem 6 6
Unintended Movement 6 6
Material Integrity Problem 5 5
Separation Failure 5 5
Power Problem 5 5
Fracture 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Material Deformation 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3166 3166
No Consequences Or Impact To Patient 1114 1114
No Known Impact Or Consequence To Patient 44 44
Insufficient Information 26 26
Burn(s) 13 13
Unspecified Tissue Injury 5 5
Brain Injury 3 3
Burn, Thermal 3 3
Full thickness (Third Degree) Burn 3 3
Superficial (First Degree) Burn 2 2
Perforation 2 2
Injury 2 2
Foreign Body In Patient 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Code Available 1 1
Chemical Exposure 1 1
Post Traumatic Wound Infection 1 1
Peroneal Nerve Palsy 1 1
Aneurysm 1 1
Tissue Damage 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 The Anspach Effort, Inc. II Jan-07-2023
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