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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 2427
Fracture 273
Material Twisted / Bent 266
Dull, Blunt 229
Material Fragmentation 224
Bent 219
Device-Device Incompatibility 101
Device Operates Differently Than Expected 85
Entrapment of Device 73
Appropriate Term/Code Not Available 63
Failure to Cut 57
Corroded 40
Naturally Worn 37
Failure to Align 33
Insufficient Information 31
Material Deformation 31
Mechanical Jam 24
Adverse Event Without Identified Device or Use Problem 23
Use of Device Problem 22
Crack 22
Device Markings / Labelling Problem 18
Physical Resistance / Sticking 16
Component Missing 16
Delivered as Unsterile Product 16
Mechanical Problem 15
Packaging Problem 13
Separation Failure 12
Tip 12
Unintended Movement 10
Device Contamination with Chemical or Other Material 9
Incorrect Measurement 9
Difficult to Remove 9
Device Handling Problem 7
Fitting Problem 6
Defective Device 6
Manufacturing, Packaging or Shipping Problem 6
Difficult to Insert 5
Temperature Problem 5
Tear, Rip or Hole in Device Packaging 5
Loss of or Failure to Bond 5
Connection Problem 5
Residue After Decontamination 4
Contamination / decontamination Problem 4
Metal Shedding Debris 4
Material Integrity Problem 4
Detachment of Device or device Component 4
Loose or Intermittent Connection 4
Scratched Material 4
Device Issue 4
Device Packaging Compromised 3
Device Contaminated during manufacture or shipping 3
Detachment Of Device Component 3
Mechanics Altered 3
Material Erosion 3
Improper or Incorrect Procedure or Method 3
Pin 3
Product Quality Problem 3
Degraded 3
Unraveled Material 3
Device Difficult to Maintain 3
Difficult or Delayed Positioning 2
Screw 2
No Apparent Adverse Event 2
Deformation Due to Compressive Stress 2
Device Inoperable 2
Device Operational Issue 2
Flaked 2
Failure to Disconnect 2
Overheating of Device 2
Sticking 2
Patient Device Interaction Problem 2
Inaccurate Information 1
Positioning Failure 1
Device Damaged by Another Device 1
Unsealed Device Packaging 1
Off-Label Use 1
Material Separation 1
Incomplete or Missing Packaging 1
Unintended Collision 1
Peeled / Delaminated 1
Inadequacy of Device Shape and/or Size 1
Device Contamination With Biological Material 1
Difficult To Position 1
Device Slipped 1
Cut In Material 1
Device Or Device Fragments Location Unknown 1
Labelling, Instructions for Use or Training Problem 1
Unable to Obtain Readings 1
Kinked 1
Positioning Problem 1
Difficult to Advance 1
Component Falling 1
Human-Device Interface Problem 1
Operating System Becomes Nonfunctional 1
Patient-Device Incompatibility 1
Optical Decentration 1
Unstable 1
Vibration 1
Failure to Capture 1
Misconnection 1
Total Device Problems 4601

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 Zimmer GmbH II May-23-2019

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