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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 2726
Material Twisted/Bent 326
Fracture 319
Dull, Blunt 304
Material Fragmentation 227
Bent 219
Device-Device Incompatibility 135
Entrapment of Device 132
Failure to Cut 108
Device Operates Differently Than Expected 85
Material Deformation 72
Appropriate Term/Code Not Available 63
Naturally Worn 48
Corroded 40
Failure to Align 33
Insufficient Information 32
Mechanical Jam 30
Adverse Event Without Identified Device or Use Problem 27
Physical Resistance/Sticking 25
Component Missing 22
Crack 22
Use of Device Problem 22
Device Markings/Labelling Problem 18
Delivered as Unsterile Product 17
Mechanical Problem 16
Packaging Problem 16
Separation Failure 13
Tip 12
Material Integrity Problem 11
Unintended Movement 10
Difficult to Remove 10
Contamination /Decontamination Problem 9
Incorrect Measurement 9
Device Contamination with Chemical or Other Material 9
Illegible Information 8
Device Contaminated During Manufacture or Shipping 7
Fitting Problem 6
Defective Device 6
Device Handling Problem 6
Improper or Incorrect Procedure or Method 6
Manufacturing, Packaging or Shipping Problem 6
Scratched Material 5
Difficult to Insert 5
Connection Problem 5
Temperature Problem 5
Tear, Rip or Hole in Device Packaging 5
Material Separation 5
Loss of or Failure to Bond 5
Metal Shedding Debris 4
Device Issue 4
Degraded 4
Loose or Intermittent Connection 4
Residue After Decontamination 4
Detachment of Device or Device Component 4
Device Packaging Compromised 3
Device Difficult to Maintain 3
Mechanics Altered 3
Pin 3
Material Erosion 3
Product Quality Problem 3
Unraveled Material 3
Detachment Of Device Component 3
Screw 2
Sticking 2
Failure to Disconnect 2
Deformation Due to Compressive Stress 2
Patient Device Interaction Problem 2
Device Operational Issue 2
No Apparent Adverse Event 2
Flaked 2
Overheating of Device 2
Device Inoperable 2
Difficult or Delayed Positioning 2
Human-Device Interface Problem 1
Patient-Device Incompatibility 1
Material Frayed 1
Labelling, Instructions for Use or Training Problem 1
Kinked 1
Optical Decentration 1
Unintended Collision 1
Off-Label Use 1
Unable to Obtain Readings 1
Unstable 1
Failure to Capture 1
Unsealed Device Packaging 1
Difficult To Position 1
Difficult or Delayed Separation 1
Device Difficult to Setup or Prepare 1
Device Slipped 1
Positioning Failure 1
Incomplete or Missing Packaging 1
Device Contamination with Body Fluid 1
Material Split, Cut or Torn 1
Activation, Positioning or SeparationProblem 1
Excessive Heating 1
Cut In Material 1
Component Falling 1
Disassembly 1
Material Disintegration 1
Device Contamination With Biological Material 1
Total Device Problems 5344

Recalls
Manufacturer Recall Class Date Posted
1 AAP Implantate Ag III Dec-22-2019
2 Biomet, Inc. II May-26-2016
3 Cayenne Medical Inc. II Jul-28-2018
4 MicroAire Surgical Instruments, LLC II Jan-26-2018
5 Synthes (USA) Products LLC II May-23-2016
6 Synthes, Inc. II Jun-04-2015
7 Tornier, Inc II May-09-2018
8 Trilliant Surgical Ltd. II Aug-24-2015
9 Trilliant Surgical, LLC II May-05-2020
10 Zimmer GmbH II May-23-2019

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