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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bit, drill
Regulation Description Orthopedic manual surgical instrument.
Product CodeHTW
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
RENOVO LIFE LLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 2194
Fracture 257
Material Fragmentation 221
Bent 219
Dull, Blunt 208
Material Twisted / Bent 204
Device Operates Differently Than Expected 89
Device-Device Incompatibility 85
Appropriate Term/Code Not Available 63
Entrapment of Device 51
Failure to Cut 45
Corroded 40
Naturally Worn 34
Failure to Align 33
Insufficient Information 30
Crack 22
Mechanical Jam 21
Use of Device Problem 20
Mechanical Problem 18
Adverse Event Without Identified Device or Use Problem 18
Device Markings / Labelling Problem 18
Component Missing 17
Delivered as Unsterile Product 16
Material Deformation 16
Tip 12
Separation Failure 12
Packaging Problem 11
Unintended Movement 10
Device Handling Problem 9
Incorrect Measurement 9
Difficult to Remove 9
Physical Resistance / Sticking 8
Device Contamination with Chemical or Other Material 7
Fitting Problem 6
Defective Device 6
Tear, Rip or Hole in Device Packaging 5
Connection Problem 5
Difficult to Insert 5
Loss of or Failure to Bond 5
Manufacturing, Packaging or Shipping Problem 5
Temperature Problem 5
Scratched Material 4
Material Integrity Problem 4
Loose or Intermittent Connection 4
Detachment of Device or device Component 4
Residue After Decontamination 4
Device Issue 4
Metal Shedding Debris 4
Unraveled Material 3
Pin 3
Detachment Of Device Component 3
Material Erosion 3
Mechanics Altered 3
Device Packaging Compromised 3
Device Difficult to Maintain 3
No Apparent Adverse Event 2
Patient Device Interaction Problem 2
Degraded 2
Difficult or Delayed Positioning 2
Positioning Failure 2
Screw 2
Product Quality Problem 2
Overheating of Device 2
Sticking 2
Device Inoperable 2
Improper or Incorrect Procedure or Method 2
Device Operational Issue 2
Deformation Due to Compressive Stress 2
Failure to Disconnect 2
Device Or Device Fragments Location Unknown 1
Patient-Device Incompatibility 1
Battery Problem 1
Contamination / decontamination Problem 1
Activation, Positioning or Separation Problem 1
Device Damaged by Another Device 1
Device Contamination With Biological Material 1
Vibration 1
Unstable 1
Cut In Material 1
Incomplete or Missing Packaging 1
Device Contamination with Body Fluid 1
Unsealed Device Packaging 1
Difficult To Position 1
Device Difficult to Setup or Prepare 1
Off-Label Use 1
Unable to Obtain Readings 1
Inadequacy of Device Shape and/or Size 1
Smoking 1
Labelling, Instructions for Use or Training Problem 1
Kinked 1
Unintended Collision 1
Misassembled 1
Misconnection 1
Disassembly 1
Material Frayed 1
Component Falling 1
Failure to Capture 1
Coiled 1
Shaft 1
Material Split, Cut or Torn 1
Total Device Problems 4176

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II May-26-2016
2 Cayenne Medical Inc. II Jul-28-2018
3 MicroAire Surgical Instruments, LLC II Jan-26-2018
4 Synthes (USA) Products LLC II May-23-2016
5 Synthes, Inc. II Jun-04-2015
6 The Anspach Effort, Inc. II Jan-11-2014
7 Tornier, Inc II May-09-2018
8 Trilliant Surgical Ltd. II Aug-24-2015
9 Zimmer GmbH II May-23-2019

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