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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 2
MEDTRONIC POWERED SURGICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZETHON LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1779 1779
2019 1703 1703
2020 1304 1304
2021 946 946
2022 761 761
2023 292 292

Device Problems MDRs with this Device Problem Events in those MDRs
Excessive Heating 1764 1764
Overheating of Device 1696 1696
Vibration 1228 1228
Unintended System Motion 573 573
Detachment of Device or Device Component 476 476
Device Damaged by Another Device 343 343
Material Twisted/Bent 309 309
Device Alarm System 263 263
Complete Loss of Power 196 196
Noise, Audible 160 160
Break 131 131
Device-Device Incompatibility 119 119
Fail-Safe Did Not Operate 117 117
Fail-Safe Problem 106 106
Material Fragmentation 96 96
Bent 84 84
Detachment Of Device Component 73 73
Appropriate Term/Code Not Available 72 72
Fracture 71 71
Mechanical Jam 52 52
Material Frayed 44 44
Output below Specifications 43 43
Leak/Splash 40 40
Device Displays Incorrect Message 38 38
Fluid/Blood Leak 37 37
Mechanical Problem 35 35
Device Operates Differently Than Expected 32 32
Separation Problem 31 31
Premature Separation 24 24
Difficult or Delayed Separation 19 19
Device Slipped 19 19
Difficult To Position 18 18
Device Reprocessing Problem 14 14
Device Inoperable 14 14
Cut In Material 11 11
Component Missing 10 10
Material Separation 10 10
Material Rupture 10 10
Environmental Particulates 10 10
Adverse Event Without Identified Device or Use Problem 9 9
Unintended Movement 9 9
Device Operational Issue 9 9
Connection Problem 8 8
Difficult to Remove 8 8
Electrical /Electronic Property Problem 8 8
Intermittent Loss of Power 8 8
Material Deformation 8 8
No Apparent Adverse Event 7 7
Dull, Blunt 7 7
Device Markings/Labelling Problem 6 6
Image Display Error/Artifact 6 6
Device Remains Activated 5 5
Physical Resistance/Sticking 5 5
Naturally Worn 5 5
Smoking 4 4
Separation Failure 4 4
Difficult to Insert 4 4
Corroded 4 4
Defective Device 3 3
Contamination /Decontamination Problem 3 3
Component or Accessory Incompatibility 3 3
Retraction Problem 3 3
Self-Activation or Keying 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Power Problem 3 3
Device Fell 3 3
Intermittent Energy Output 2 2
Mechanics Altered 2 2
Moisture or Humidity Problem 2 2
Device Stops Intermittently 2 2
Metal Shedding Debris 2 2
Defective Component 2 2
Degraded 2 2
Display or Visual Feedback Problem 2 2
Disconnection 2 2
Misconnection 2 2
Loose or Intermittent Connection 2 2
Loss of Power 1 1
Energy Output Problem 1 1
Output above Specifications 1 1
Energy Spectrum Incorrect 1 1
Material Disintegration 1 1
Positioning Failure 1 1
Crack 1 1
Intermittent Continuity 1 1
Circuit Failure 1 1
Air Leak 1 1
False Alarm 1 1
Defective Alarm 1 1
Difficult to Open or Remove Packaging Material 1 1
Application Program Problem 1 1
Structural Problem 1 1
Dent in Material 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Unstable 1 1
Use of Device Problem 1 1
Excessive Cooling 1 1
Failure to Auto Stop 1 1
Protective Measures Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 3484 3484
No Clinical Signs, Symptoms or Conditions 2120 2120
No Known Impact Or Consequence To Patient 1091 1091
No Patient Involvement 24 24
Insufficient Information 18 18
Burn(s) 13 13
Foreign Body In Patient 13 13
Patient Problem/Medical Problem 12 12
Brain Injury 9 9
Nervous System Injury 8 8
Death 5 5
Burn, Thermal 5 5
Tissue Damage 4 4
Not Applicable 4 4
No Code Available 3 3
Injury 3 3
Blood Loss 2 2
Perforation 2 2
Unspecified Tissue Injury 2 2
Full thickness (Third Degree) Burn 2 2
Failure of Implant 2 2
Superficial (First Degree) Burn 2 2
Skull Fracture 1 1
Chemical Exposure 1 1
Aneurysm 1 1
Device Embedded In Tissue or Plaque 1 1
Peroneal Nerve Palsy 1 1
Post Traumatic Wound Infection 1 1
No Information 1 1
Hemorrhage/Bleeding 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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