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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device reamer
Regulation Description Orthopedic manual surgical instrument.
Product CodeHTO
Regulation Number 888.4540
Device Class 1

Device Problems
Dull, Blunt 3438
Break 980
Corroded 742
Naturally Worn 387
Appropriate Term/Code Not Available 318
Failure to Cut 292
Material Twisted / Bent 253
Material Deformation 232
Device-Device Incompatibility 148
Crack 134
Adverse Event Without Identified Device or Use Problem 125
Material Discolored 112
Material Fragmentation 104
Fracture 74
Scratched Material 50
Device Contamination with Chemical or Other Material 49
Pitted 47
Mechanical Jam 37
Device Operates Differently Than Expected 34
Detachment of Device or device Component 32
Entrapment of Device 29
Component Missing 28
Insufficient Information 26
Loose or Intermittent Connection 23
Bent 22
Connection Problem 21
Fitting Problem 21
Difficult to Insert 18
Physical Resistance / Sticking 17
Material Erosion 15
Contamination / decontamination Problem 15
Disassembly 14
Difficult to Remove 12
Mechanical Problem 10
Device Disinfection Or Sterilization Issue 7
Failure To Adhere Or Bond 7
Product Quality Problem 7
Tip 7
No Apparent Adverse Event 6
Device Reprocessing Problem 6
Detachment Of Device Component 6
Peeled / Delaminated 6
Sticking 5
Failure to Clean Adequately 5
Device Slipped 5
Difficult to Open or Close 5
Use of Device Problem 5
Metal Shedding Debris 5
Illegible Information 4
Failure to Advance 4
Packaging Problem 4
Component Falling 4
Positioning Failure 4
Complete Blockage 3
Separation Failure 3
Positioning Problem 3
Material Integrity Problem 3
Patient-Device Incompatibility 3
Loss of or Failure to Bond 3
Delivered as Unsterile Product 2
Device Difficult to Maintain 2
Problem with Sterilization 2
Defective Component 2
Device Damaged Prior to Use 2
Difficult to Advance 2
Material Distortion 2
Cut In Material 2
Failure to Align 2
Off-Label Use 2
Material Separation 1
Device Issue 1
Hole In Material 1
Unsealed Device Packaging 1
Unintended Movement 1
Unintended Collision 1
Dent in Material 1
Device Or Device Fragments Location Unknown 1
Difficult To Position 1
Difficult to Open or Remove Packaging Material 1
Separation Problem 1
Device Markings / Labelling Problem 1
Flaked 1
Monitor failure 1
Malposition of device 1
Device Fell 1
Compatibility Problem 1
Device Stops Intermittently 1
Device Inoperable 1
Improper or Incorrect Procedure or Method 1
Guidewire 1
Misconnection 1
Communication or Transmission Problem 1
Migration or Expulsion of Device 1
Measurement System Incompatibility 1
Optical Discoloration 1
Misassembled During Installation 1
Shaft 1
Difficult or Delayed Positioning 1
Misassembled 1
Electrical Power Problem 1
Total Device Problems 8030

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Nov-09-2018
2 Biomet, Inc. II May-26-2016
3 Cayenne Medical Inc. II Jul-25-2018
4 Encore Medical, Lp II Aug-31-2017
5 Synthes (USA) Products LLC II Mar-05-2018
6 Synthes (USA) Products LLC II Nov-23-2016
7 Synthes (USA) Products LLC II Nov-19-2016
8 Synthes (USA) Products LLC II Jun-06-2016
9 Synthes (USA) Products LLC II Jan-05-2016
10 Synthes (USA) Products LLC II Aug-10-2015
11 Synthes, Inc. II Jul-16-2015
12 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Mar-20-2020
13 Trilliant Surgical Ltd. II Aug-24-2015

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