Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device motor, drill, electric
Product CodeHBC
Regulation Number 882.4360
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIEN-AIR SURGERY SA
  SUBSTANTIALLY EQUIVALENT 2
LINVATEC CORPORATION D/B/A CONMED LINVATEC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC POWERED SURGICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 3
NAKANISHI, INC.
  SUBSTANTIALLY EQUIVALENT 2
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZETHON LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2643 2643
2015 1953 1953
2016 2541 2541
2017 2079 2079
2018 1779 1779
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
Overheating of Device 4618 4618
Excessive Heating 1988 1988
Vibration 1817 1817
Break 1488 1488
Device Operates Differently Than Expected 848 848
Device Displays Incorrect Message 841 841
Unintended System Motion 791 791
Device Inoperable 745 745
Temperature Problem 715 715
Noise, Audible 689 689
Detachment of Device or Device Component 550 550
Bent 480 480
Naturally Worn 444 444
Device Damaged by Another Device 426 426
Detachment Of Device Component 346 346
Material Twisted/Bent 310 310
Fail-Safe Problem 304 304
Device Alarm System 290 290
Complete Loss of Power 250 250
Defective Device 183 183
Mechanical Problem 176 176
Defective Component 165 165
Loose or Intermittent Connection 159 159
Component Missing 155 155
Sticking 146 146
Device-Device Incompatibility 137 137
Fail-Safe Did Not Operate 129 129
Fracture 124 124
Loss of Power 123 123
Device Stops Intermittently 122 122
Smoking 118 118
Material Fragmentation 117 117
Cut In Material 103 103
Device Slipped 103 103
Mechanical Jam 100 100
Appropriate Term/Code Not Available 98 98
Material Separation 87 87
Hole In Material 84 84
Leak/Splash 77 77
Difficult to Insert 71 71
Corroded 71 71
Moisture Damage 68 68
Fluid/Blood Leak 67 67
Fitting Problem 67 67
Material Frayed 66 66
Torn Material 66 66
Output below Specifications 61 61
Difficult To Position 58 58
Failure to Power Up 54 54
Difficult to Remove 48 48
Crack 47 47
Component Falling 47 47
Positioning Problem 46 46
Connection Problem 42 42
Separation Problem 41 41
Material Deformation 41 41
Protective Measures Problem 39 39
Electrical /Electronic Property Problem 36 36
Incorrect Or Inadequate Test Results 35 35
Material Protrusion/Extrusion 33 33
Self-Activation or Keying 31 31
Unstable 30 30
Premature Separation 30 30
Unintended Movement 29 29
Power Problem 28 28
Difficult or Delayed Separation 26 26
Device Operational Issue 25 25
Adverse Event Without Identified Device or Use Problem 22 22
Material Integrity Problem 22 22
Physical Property Issue 19 19
Thermal Decomposition of Device 19 19
Device Markings/Labelling Problem 18 18
Material Rupture 18 18
Degraded 17 17
Scratched Material 17 17
Failure of Device to Self-Test 17 17
Device Contamination with Chemical or Other Material 17 17
Device Reprocessing Problem 16 16
Environmental Particulates 14 14
Dull, Blunt 13 13
Air Leak 12 12
Partial Blockage 12 12
Moisture or Humidity Problem 12 12
No Apparent Adverse Event 11 11
Insufficient Information 11 11
Failure to Cut 11 11
Malposition of Device 9 9
Metal Shedding Debris 9 9
Device Dislodged or Dislocated 9 9
Device Sensing Problem 8 8
Intermittent Loss of Power 8 8
Contamination 8 8
Device Emits Odor 8 8
Migration or Expulsion of Device 7 7
Material Discolored 7 7
Failure To Adhere Or Bond 7 7
Structural Problem 7 7
Failure to Advance 7 7
Failure to Shut Off 7 7
Split 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6174 6174
No Consequences Or Impact To Patient 3969 3969
No Patient Involvement 3474 3474
No Clinical Signs, Symptoms or Conditions 2543 2543
No Information 145 145
Burn(s) 33 33
No Code Available 19 19
Insufficient Information 18 18
Foreign Body In Patient 17 17
Device Embedded In Tissue or Plaque 15 15
Patient Problem/Medical Problem 14 14
Tissue Damage 13 13
Brain Injury 13 13
Burn, Thermal 9 9
Nervous System Injury 8 8
Injury 7 7
Death 5 5
Not Applicable 5 5
Unspecified Tissue Injury 5 5
Full thickness (Third Degree) Burn 4 4
Perforation 4 4
Failure of Implant 2 2
Blood Loss 2 2
Confusion/ Disorientation 2 2
Irritability 2 2
Superficial (First Degree) Burn 2 2
Partial thickness (Second Degree) Burn 1 1
Unintended Radiation Exposure 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Neck Stiffness 1 1
Post Traumatic Wound Infection 1 1
Sleep Dysfunction 1 1
Electric Shock 1 1
Chemical Exposure 1 1
Peroneal Nerve Palsy 1 1
Disc Impingement 1 1
Unspecified Infection 1 1
Inflammation 1 1
Laceration(s) 1 1
Pain 1 1
Skull Fracture 1 1
Swelling 1 1
Complaint, Ill-Defined 1 1
Debris, Bone Shedding 1 1
Hemorrhage/Bleeding 1 1
Abrasion 1 1
Abscess 1 1
Aneurysm 1 1
Apnea 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Inc II Mar-02-2011
2 The Anspach Effort, Inc. II Jan-07-2023
3 The Anspach Effort, Inc. II May-04-2017
4 The Anspach Effort, Inc. II Jul-21-2016
5 The Anspach Effort, Inc. II Feb-02-2015
6 The Anspach Effort, Inc. II Jun-25-2014
7 The Anspach Effort, Inc. II Jan-27-2014
8 The Anspach Effort, Inc. II Nov-13-2013
9 The Anspach Effort, Inc. II Sep-14-2011
10 The Anspach Effort, Inc. II Sep-13-2011
-
-