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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 1
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K220485  Wireless Hand Control, EG1A (WIRELESS-HC), Receive ...
ZETHON LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1703 1703
2020 1304 1304
2021 946 946
2022 760 760
2023 664 664
2024 59 59

Device Problems MDRs with this Device Problem Events in those MDRs
Excessive Heating 1983 1983
Vibration 953 953
Overheating of Device 823 823
Unintended System Motion 427 427
Device Damaged by Another Device 420 420
Detachment of Device or Device Component 412 412
Device Alarm System 276 276
Complete Loss of Power 250 250
Noise, Audible 169 169
Material Twisted/Bent 156 156
Break 147 147
Device-Device Incompatibility 135 135
Fail-Safe Did Not Operate 129 129
Material Fragmentation 108 108
Appropriate Term/Code Not Available 92 92
Mechanical Jam 56 56
Material Frayed 47 47
Leak/Splash 42 42
Separation Problem 41 41
Output below Specifications 39 39
Fail-Safe Problem 33 33
Fracture 31 31
Premature Separation 30 30
Difficult or Delayed Separation 26 26
Mechanical Problem 23 23
Device Slipped 23 23
Fluid/Blood Leak 22 22
Device Reprocessing Problem 15 15
Environmental Particulates 14 14
No Apparent Adverse Event 11 11
Unintended Movement 9 9
Component Missing 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Electrical /Electronic Property Problem 9 9
Intermittent Loss of Power 8 8
Dull, Blunt 7 7
Device Markings/Labelling Problem 7 7
Connection Problem 6 6
Separation Failure 5 5
Physical Resistance/Sticking 5 5
Manufacturing, Packaging or Shipping Problem 4 4
Corroded 4 4
Device Remains Activated 4 4
Material Rupture 4 4
Self-Activation or Keying 3 3
Retraction Problem 3 3
Naturally Worn 3 3
Power Problem 3 3
Contamination /Decontamination Problem 3 3
Component or Accessory Incompatibility 3 3
Device Fell 3 3
Intermittent Energy Output 2 2
Device Displays Incorrect Message 2 2
Mechanics Altered 2 2
Material Deformation 2 2
Loss of Power 2 2
Display or Visual Feedback Problem 2 2
Degraded 2 2
Misconnection 2 2
Positioning Failure 1 1
Energy Spectrum Incorrect 1 1
Crack 1 1
Intermittent Continuity 1 1
Circuit Failure 1 1
False Alarm 1 1
Defective Alarm 1 1
Energy Output Problem 1 1
Output above Specifications 1 1
Product Quality Problem 1 1
Material Separation 1 1
Device Damaged Prior to Use 1 1
Smoking 1 1
Unstable 1 1
Use of Device Problem 1 1
Failure to Auto Stop 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Packaging Problem 1 1
Component Misassembled 1 1
Material Too Soft/Flexible 1 1
Failure to Eject 1 1
Application Program Problem 1 1
Defective Device 1 1
Structural Problem 1 1
Excessive Cooling 1 1
Difficult to Open or Remove Packaging Material 1 1
Incomplete or Inadequate Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2542 2542
No Consequences Or Impact To Patient 2298 2298
No Known Impact Or Consequence To Patient 548 548
Insufficient Information 18 18
Burn(s) 11 11
Foreign Body In Patient 6 6
Unspecified Tissue Injury 5 5
Full thickness (Third Degree) Burn 3 3
Tissue Damage 3 3
Burn, Thermal 3 3
Failure of Implant 2 2
Perforation 2 2
Brain Injury 2 2
Injury 2 2
Superficial (First Degree) Burn 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Unintended Radiation Exposure 1 1
Patient Problem/Medical Problem 1 1
Peroneal Nerve Palsy 1 1
Post Traumatic Wound Infection 1 1
Hemorrhage/Bleeding 1 1
Chemical Exposure 1 1
No Patient Involvement 1 1
Aneurysm 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
No Code Available 1 1

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