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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 3568
Break 1060
Corroded 745
Failure to Cut 438
Naturally Worn 399
Material Twisted/Bent 331
Appropriate Term/Code Not Available 318
Material Deformation 239
Device-Device Incompatibility 166
Crack 154
Adverse Event Without Identified Device or Use Problem 125
Material Discolored 113
Material Fragmentation 104
Fracture 76
Illegible Information 66
Scratched Material 63
Device Contamination with Chemical or Other Material 49
Pitted 47
Entrapment of Device 44
Detachment of Device or Device Component 41
Component Missing 40
Mechanical Jam 38
Contamination /Decontamination Problem 35
Device Operates Differently Than Expected 34
Insufficient Information 26
Loose or Intermittent Connection 23
Bent 22
Fitting Problem 21
Connection Problem 21
Physical Resistance/Sticking 19
Difficult to Insert 18
Material Erosion 15
Disassembly 14
Difficult to Remove 12
Mechanical Problem 11
Failure To Adhere Or Bond 7
Device Disinfection Or Sterilization Issue 7
Product Quality Problem 7
Tip 7
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
Peeled/Delaminated 5
Material Integrity Problem 5
Use of Device Problem 5
Failure to Advance 4
Component Falling 4
Packaging Problem 4
Positioning Failure 4
Separation Failure 3
Device Damaged Prior to Use 3
Patient-Device Incompatibility 3
Loss of or Failure to Bond 3
Positioning Problem 3
Complete Blockage 3
Cut In Material 2
Difficult to Advance 2
Delivered as Unsterile Product 2
Defective Component 2
Failure to Align 2
Off-Label Use 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
Device Markings/Labelling Problem 1
Difficult to Open or Remove Packaging Material 1
Manufacturing, Packaging or Shipping Problem 1
Separation Problem 1
Output below Specifications 1
Misconnection 1
Material Separation 1
Inadequacy of Device Shape and/or Size 1
Device Stops Intermittently 1
Device Or Device Fragments Location Unknown 1
Electrical Power Problem 1
Dent in Material 1
Failure to Auto Stop 1
Compatibility Problem 1
Device Issue 1
Overfill 1
Communication or Transmission Problem 1
Total Device Problems 8664

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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