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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)
Regulation Description Powered simple cranial drills, burrs, trephines, and their accessories.
Product CodeHBE
Regulation Number 882.4310
Device Class 2


Premarket Reviews
ManufacturerDecision
ADEOR MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
AD-TECH
  SUBSTANTIALLY EQUIVALENT 1
AD-TECH MEDICAL INSTRUMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOTEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MRI INTERVENTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 4
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Overheating of Device 1116
Flaked 621
Break 465
Fracture 172
Disassembly 94
Bent 82
Vibration 60
Detachment of Device or device Component 47
Device Operates Differently Than Expected 28
Device Inoperable 25
Mechanical Problem 24
Material Twisted / Bent 22
Noise, Audible 21
Detachment Of Device Component 20
Material Fragmentation 16
Fluid Leak 14
Leak / Splash 12
Device Displays Incorrect Message 12
Sticking 11
Material Separation 9
Temperature Problem 9
Smoking 8
Difficult to Remove 8
Device Remains Activated 7
Packaging Problem 7
Difficult To Position 6
Self-Activation or Keying 6
Tip 6
Cutter 6
Defective Component 5
Bearings 5
Connection Problem 5
Unintended System Motion 5
Adverse Event Without Identified Device or Use Problem 4
Shaft 4
Use of Device Problem 4
Metal Shedding Debris 4
Material Deformation 4
Mechanical Jam 3
Difficult to Insert 3
Dull, Blunt 3
Material Integrity Problem 3
Unstable 3
Material Disintegration 3
Failure To Adhere Or Bond 2
Component Missing 2
No Apparent Adverse Event 2
Unintended power up 2
Delivered as Unsterile Product 2
Output below Specifications 2
Loose or Intermittent Connection 2
Insufficient Information 2
Unintended Movement 2
Peeled / Delaminated 2
Inadequacy of Device Shape and/or Size 1
Fitting Problem 1
Cover 1
Guide 1
Partial Blockage 1
Device Subassembly 1
Excessive Heating 1
Locking Mechanism 1
Tube 1
Material Protrusion / Extrusion 1
Device Emits Odor 1
Failure to Power Up 1
Naturally Worn 1
Gears 1
Charred 1
Ambient Noise Problem 1
Biocompatibility 1
Device Markings / Labelling Problem 1
Positioning Problem 1
Device Alarm System 1
Thermal Decomposition of Device 1
Component Falling 1
Computer Software Problem 1
Ventilation Problem in Device Environment 1
Misfire 1
Fail-Safe Problem 1
Contamination / decontamination Problem 1
Deformation Due to Compressive Stress 1
Material Discolored 1
Misconnection 1
Device Stops Intermittently 1
Handpiece 1
Total Device Problems 3044

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 EXP Pharmaceutical Services Corp II Jul-24-2015
4 Medtronic Sofamor Danek Usa, Inc - Dallas Distribution II Jun-28-2016
5 Stryker Instruments Div. of Stryker Corporation II Dec-21-2016
6 Stryker Instruments Div. of Stryker Corporation II Jul-19-2016
7 Stryker Instruments Div. of Stryker Corporation II Jul-14-2016
8 Stryker Instruments Div. of Stryker Corporation II Jun-11-2014
9 The Anspach Effort, Inc. II May-04-2017
10 The Anspach Effort, Inc. II Sep-16-2016
11 The Anspach Effort, Inc. II Jul-29-2015
12 The Anspach Effort, Inc. II Jun-25-2014
13 The Anspach Effort, Inc. II Jan-15-2014
14 The Anspach Effort, Inc. II Jan-13-2014
15 The Anspach Effort, Inc. II Jan-10-2014
16 The Anspach Effort, Inc. II Jan-09-2014

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