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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

MDR Year MDR Reports MDR Events
2016 1039 1039
2017 1234 1234
2018 1835 1835
2019 1954 1954
2020 1531 1531
2021 1299 1299

Device Problems MDRs with this Device Problem Events in those MDRs
Dull, Blunt 3345 3345
Failure to Cut 1958 1958
Break 1228 1228
Corroded 1046 1046
Material Twisted/Bent 533 533
Naturally Worn 408 408
Appropriate Term/Code Not Available 323 323
Material Deformation 257 257
Device-Device Incompatibility 233 233
Illegible Information 218 218
Crack 169 169
Adverse Event Without Identified Device or Use Problem 152 152
Material Discolored 115 115
Entrapment of Device 110 110
Material Fragmentation 89 89
Fracture 75 75
Scratched Material 68 68
Detachment of Device or Device Component 51 51
Mechanical Jam 50 50
Device Contamination with Chemical or Other Material 49 49
Pitted 47 47
Contamination /Decontamination Problem 46 46
Loose or Intermittent Connection 44 44
Component Missing 37 37
Device Operates Differently Than Expected 36 36
Insufficient Information 26 26
Physical Resistance/Sticking 21 21
Difficult to Insert 20 20
Bent 20 20
Connection Problem 19 19
Fitting Problem 15 15
Material Erosion 15 15
Disassembly 15 15
Mechanical Problem 12 12
Material Integrity Problem 10 10
Detachment Of Device Component 9 9
Difficult to Remove 9 9
Use of Device Problem 8 8
Peeled/Delaminated 8 8
Product Quality Problem 8 8
Device Disinfection Or Sterilization Issue 7 7
No Apparent Adverse Event 7 7
Device Reprocessing Problem 6 6
Failure To Adhere Or Bond 6 6
Failure to Clean Adequately 5 5
Device Slipped 5 5
Difficult to Open or Close 5 5
Packaging Problem 4 4
Metal Shedding Debris 4 4
Patient-Device Incompatibility 4 4
Positioning Failure 4 4
Component Falling 4 4
Failure to Advance 4 4
Device Damaged Prior to Use 3 3
Defective Component 3 3
Positioning Problem 3 3
Unintended Movement 3 3
Degraded 3 3
Loss of or Failure to Bond 3 3
Cut In Material 2 2
Failure to Align 2 2
Separation Failure 2 2
Problem with Sterilization 2 2
Off-Label Use 2 2
Material Split, Cut or Torn 2 2
Device Dislodged or Dislocated 2 2
Device Difficult to Maintain 2 2
Material Distortion 2 2
Delivered as Unsterile Product 2 2
Improper or Incorrect Procedure or Method 2 2
Difficult to Advance 2 2
Inadequacy of Device Shape and/or Size 2 2
Sticking 1 1
Device Stops Intermittently 1 1
Misassembled 1 1
Misconnection 1 1
Difficult or Delayed Positioning 1 1
Flaked 1 1
Electrical Power Problem 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Markings/Labelling Problem 1 1
Dent in Material 1 1
Battery Problem 1 1
Output below Specifications 1 1
Device Fell 1 1
Measurement System Incompatibility 1 1
Difficult to Open or Remove Packaging Material 1 1
Separation Problem 1 1
Misassembled During Installation 1 1
Optical Discoloration 1 1
Material Puncture/Hole 1 1
Material Separation 1 1
Microbial Contamination of Device 1 1
Device Issue 1 1
Overfill 1 1
Communication or Transmission Problem 1 1
Device Tipped Over 1 1
Device Or Device Fragments Location Unknown 1 1
Complete Blockage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 4912 4912
No Clinical Signs, Symptoms or Conditions 1522 1522
No Information 1147 1147
No Known Impact Or Consequence To Patient 650 650
No Code Available 527 527
No Patient Involvement 231 231
Not Applicable 218 218
Insufficient Information 176 176
Foreign Body In Patient 165 165
Device Embedded In Tissue or Plaque 66 66
Bone Fracture(s) 63 63
Injury 31 31
Pain 30 30
Unspecified Infection 19 19
Blood Loss 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Sedation 13 13
Non-union Bone Fracture 10 10
Failure of Implant 6 6
Hip Fracture 4 4
Low Blood Pressure/ Hypotension 3 3
Limb Fracture 3 3
Patient Problem/Medical Problem 2 2
Tissue Damage 2 2
Embolism 2 2
Impaired Healing 2 2
Alteration In Body Temperature 1 1
Discomfort 1 1
Joint Disorder 1 1
Nerve Damage 1 1
Respiratory Distress 1 1
Hemorrhage/Bleeding 1 1
Bradycardia 1 1
Death 1 1
Unspecified Tissue Injury 1 1
Physical Entrapment 1 1
Neurological Deficit/Dysfunction 1 1
Loss of Range of Motion 1 1
Staphylococcus Aureus 1 1
Host-Tissue Reaction 1 1
Pulmonary Embolism 1 1
Anemia 1 1
Hematoma 1 1

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 Dec-15-2020
6 Synthes (USA) Products LLC II Mar-05-2018
7 Synthes (USA) Products LLC II Nov-23-2016
8 Synthes (USA) Products LLC II Nov-19-2016
9 Synthes (USA) Products LLC II Jun-06-2016
10 Synthes (USA) Products LLC II Jan-05-2016
11 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Mar-20-2020
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