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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
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
HUBLY INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC POWERED SURGICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NAKANISHI INC.
  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
2018 787 6375
2019 836 8856
2020 1025 10801
2021 1047 10601
2022 900 7868
2023 392 3335

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 1887 11364
Fracture 1044 1198
Flaked 746 32993
Break 466 545
Vibration 243 243
Detachment of Device or Device Component 182 247
Excessive Heating 151 151
Material Fragmentation 109 111
Material Twisted/Bent 82 961
Noise, Audible 77 77
No Apparent Adverse Event 60 60
Physical Resistance/Sticking 45 45
Fluid/Blood Leak 40 50
Mechanical Problem 38 38
Mechanical Jam 35 35
Use of Device Problem 34 34
Separation Problem 33 33
Connection Problem 27 27
Device Remains Activated 25 25
Smoking 25 25
Electrical /Electronic Property Problem 21 21
Dull, Blunt 20 20
Material Separation 19 19
Defective Component 17 17
Material Deformation 17 22
Complete Loss of Power 14 14
Material Disintegration 14 17
Bent 13 91
Material Integrity Problem 12 12
Adverse Event Without Identified Device or Use Problem 11 11
Self-Activation or Keying 10 10
Display or Visual Feedback Problem 9 9
Delivered as Unsterile Product 9 9
Intermittent Loss of Power 9 9
Unintended Movement 9 9
Appropriate Term/Code Not Available 9 9
Packaging Problem 8 8
Difficult to Remove 8 8
Tear, Rip or Hole in Device Packaging 8 8
Device-Device Incompatibility 8 8
Entrapment of Device 7 7
Computer Software Problem 7 7
Insufficient Information 7 7
Device Operates Differently Than Expected 6 6
Mechanics Altered 6 6
Naturally Worn 6 6
Loss of Power 6 6
Expiration Date Error 6 6
Device Displays Incorrect Message 5 5
Unintended System Motion 5 5
Misconnection 5 5
Difficult to Insert 5 5
Intermittent Continuity 5 5
Disassembly 5 6
Fail-Safe Did Not Operate 5 5
Environmental Particulates 4 4
Output Problem 4 4
Corroded 4 54
Image Display Error/Artifact 4 4
Fitting Problem 4 4
Defective Device 4 4
Unstable 3 3
Leak/Splash 3 3
Failure to Power Up 3 3
Peeled/Delaminated 3 3
Degraded 3 3
Circuit Failure 3 3
Detachment Of Device Component 3 3
Power Problem 3 3
Premature Separation 3 3
Inadequate Lubrication 2 26
Operating System Becomes Nonfunctional 2 2
Output below Specifications 2 2
Fail-Safe Problem 2 2
Device Dislodged or Dislocated 2 2
Temperature Problem 2 2
Intermittent Communication Failure 2 2
Nonstandard Device 2 2
Device Emits Odor 2 2
Loose or Intermittent Connection 2 2
Device Slipped 2 2
Metal Shedding Debris 2 2
Improper or Incorrect Procedure or Method 2 2
Component Missing 2 2
Communication or Transmission Problem 2 2
Blocked Connection 2 2
Deformation Due to Compressive Stress 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Markings/Labelling Problem 1 1
Sparking 1 1
Misfire 1 1
Difficult or Delayed Activation 1 1
Failure to Calibrate 1 1
Failure to Align 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Inoperable 1 1
Inability to Irrigate 1 1
Imprecision 1 1
Material Frayed 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2542 28815
No Consequences Or Impact To Patient 1090 7599
No Patient Involvement 888 17407
No Known Impact Or Consequence To Patient 547 4313
Insufficient Information 57 1382
Device Embedded In Tissue or Plaque 56 56
Foreign Body In Patient 55 55
Burn(s) 41 567
Superficial (First Degree) Burn 24 376
No Information 24 134
Unintended Radiation Exposure 22 22
Injury 21 21
Perforation 18 18
Radiation Exposure, Unintended 12 12
Hemorrhage/Bleeding 11 11
Chemical Exposure 10 10
Burn, Thermal 6 107
Abrasion 5 5
Pain 5 5
Unspecified Tissue Injury 5 5
Paresis 4 4
Numbness 4 4
Spinal Cord Injury 4 4
Blood Loss 4 4
No Code Available 3 3
Swelling/ Edema 2 2
Partial thickness (Second Degree) Burn 2 7
Patient Problem/Medical Problem 2 2
Tissue Damage 2 2
Perforation of Vessels 1 1
Pulmonary Dysfunction 1 1
Coma 1 1
Brain Injury 1 1
Failure of Implant 1 1
Oversedation 1 1
Cerebrospinal Fluid Leakage 1 1
Contusion 1 1
Death 1 1
Erythema 1 1
Hematoma 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
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