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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
Fitting Problem 21
Connection Problem 21
Difficult to Insert 18
Physical Resistance / Sticking 17
Contamination / decontamination Problem 15
Material Erosion 15
Disassembly 14
Difficult to Remove 12
Mechanical Problem 10
Failure To Adhere Or Bond 7
Device Disinfection Or Sterilization Issue 7
Product Quality Problem 7
Tip 7
Peeled / Delaminated 6
Device Reprocessing Problem 6
Detachment Of Device Component 6
No Apparent Adverse Event 6
Device Slipped 5
Difficult to Open or Close 5
Metal Shedding Debris 5
Sticking 5
Failure to Clean Adequately 5
Use of Device Problem 5
Illegible Information 4
Failure to Advance 4
Component Falling 4
Packaging Problem 4
Positioning Failure 4
Separation Failure 3
Patient-Device Incompatibility 3
Loss of or Failure to Bond 3
Positioning Problem 3
Complete Blockage 3
Material Integrity Problem 3
Difficult to Advance 2
Cut In Material 2
Delivered as Unsterile Product 2
Off-Label Use 2
Device Damaged Prior to Use 2
Defective Component 2
Failure to Align 2
Problem with Sterilization 2
Material Distortion 2
Device Difficult to Maintain 2
Measurement System Incompatibility 1
Misassembled During Installation 1
Device Inoperable 1
Malposition of device 1
Monitor failure 1
Unsealed Device Packaging 1
Difficult To Position 1
Flaked 1
Hole In Material 1
Improper or Incorrect Procedure or Method 1
Optical Discoloration 1
Material Split, Cut or Torn 1
Difficult or Delayed Positioning 1
Unintended Collision 1
Separation Problem 1
Device Markings / Labelling Problem 1
Difficult to Open or Remove Packaging Material 1
Output below Specifications 1
Misconnection 1
Material Separation 1
Device Stops Intermittently 1
Device Or Device Fragments Location Unknown 1
Electrical Power Problem 1
Dent in Material 1
Unintended Movement 1
Device Fell 1
Failure to Auto Stop 1
Compatibility Problem 1
Device Issue 1
Overfill 1
Communication or Transmission 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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