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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device drills, burrs, trephines & accessories (simple, powered)
Product CodeHBE
Regulation Number 882.4310
Device Class 2


Premarket Reviews
ManufacturerDecision
AD-TECH MEDICAL INSTRUMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ADEOR MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP INC.
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOMET MICOFIXATION
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MICROFIXATION
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC POWERED SURGICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NAKANISHI INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 848 2252
2018 787 6375
2019 836 8856
2020 1025 10801
2021 1047 10601
2022 788 7749

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 2032 10492
Fracture 946 1083
Flaked 933 32614
Break 573 677
Vibration 257 257
Detachment of Device or Device Component 166 219
Excessive Heating 138 138
Material Fragmentation 101 103
Material Twisted/Bent 80 959
Noise, Audible 76 76
Mechanical Problem 45 45
No Apparent Adverse Event 44 44
Physical Resistance/Sticking 42 42
Bent 36 213
Fluid/Blood Leak 35 41
Use of Device Problem 33 33
Separation Problem 33 33
Mechanical Jam 31 31
Smoking 27 27
Connection Problem 27 27
Device Remains Activated 23 23
Material Separation 21 21
Detachment Of Device Component 21 21
Defective Component 20 20
Dull, Blunt 19 19
Material Deformation 18 23
Device Operates Differently Than Expected 17 17
Electrical /Electronic Property Problem 17 17
Disassembly 17 23
Difficult to Remove 15 15
Device Inoperable 14 14
Complete Loss of Power 13 13
Material Integrity Problem 12 12
Self-Activation or Keying 12 12
Adverse Event Without Identified Device or Use Problem 11 11
Unintended System Motion 10 10
Display or Visual Feedback Problem 9 9
Unintended Movement 9 9
Packaging Problem 8 8
Intermittent Loss of Power 7 7
Insufficient Information 7 7
Appropriate Term/Code Not Available 7 7
Device-Device Incompatibility 7 7
Delivered as Unsterile Product 7 7
Leak/Splash 7 8
Entrapment of Device 7 7
Computer Software Problem 7 7
Tear, Rip or Hole in Device Packaging 7 7
Loss of Power 6 6
Material Disintegration 6 7
Misconnection 6 6
Mechanics Altered 6 6
Naturally Worn 5 5
Fail-Safe Did Not Operate 4 4
Output Problem 4 4
Image Display Error/Artifact 4 4
Difficult to Insert 4 4
Intermittent Continuity 4 4
Corroded 4 54
Peeled/Delaminated 4 4
Difficult To Position 4 4
Defective Device 4 4
Device Displays Incorrect Message 4 4
Fitting Problem 3 3
Failure to Power Up 3 3
Unstable 3 3
Metal Shedding Debris 3 3
Degraded 3 3
Circuit Failure 3 3
Loose or Intermittent Connection 3 3
Premature Separation 3 3
Fail-Safe Problem 3 3
Device Dislodged or Dislocated 3 3
Power Problem 3 3
Operating System Becomes Nonfunctional 2 2
Output below Specifications 2 2
Temperature Problem 2 2
Environmental Particulates 2 2
Intermittent Communication Failure 2 2
Inadequate Lubrication 2 26
Nonstandard Device 2 2
Device Emits Odor 2 2
Failure To Adhere Or Bond 2 2
Improper or Incorrect Procedure or Method 2 2
Device Slipped 2 2
Component Missing 2 2
Expiration Date Error 2 2
Communication or Transmission Problem 2 2
Blocked Connection 2 2
Deformation Due to Compressive Stress 1 1
Sparking 1 1
Biocompatibility 1 4
Misfire 1 1
Difficult or Delayed Activation 1 1
Failure to Calibrate 1 1
Failure to Align 1 1
Device Stops Intermittently 1 1
Off-Label Use 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Alarm System 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2073 25396
No Patient Involvement 1372 18856
No Consequences Or Impact To Patient 1283 8030
No Known Impact Or Consequence To Patient 689 4675
Device Embedded In Tissue or Plaque 56 56
Foreign Body In Patient 56 60
Insufficient Information 44 975
Burn(s) 34 237
No Information 30 140
Superficial (First Degree) Burn 22 374
Injury 21 21
Unintended Radiation Exposure 18 18
Perforation 17 17
Radiation Exposure, Unintended 16 16
Chemical Exposure 10 10
Hemorrhage/Bleeding 9 9
No Code Available 8 8
Burn, Thermal 6 107
Partial thickness (Second Degree) Burn 5 10
Abrasion 5 5
Blood Loss 4 4
Spinal Cord Injury 3 3
Unspecified Tissue Injury 3 3
Tissue Damage 3 3
Brain Injury 2 2
Pain 2 2
Patient Problem/Medical Problem 2 2
Swelling/ Edema 2 2
Needle Stick/Puncture 1 1
Paresis 1 1
Failure of Implant 1 1
Oversedation 1 1
Cerebrospinal Fluid Leakage 1 1
Contusion 1 1
Death 1 1
Hematoma 1 1
Coma 1 1
Sprain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ad-Tech Medical Instrument Corporation II Jul-25-2018
2 Aesculap Implant Systems LLC II Feb-15-2018
3 Medtronic Xomed, Inc. II Oct-21-2021
4 Stryker Instruments II Jul-28-2022
5 The Anspach Effort, Inc. II May-04-2017
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