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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reamer
Product CodeHTO
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
SYNTHES (USA) PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 404 404
2015 654 654
2016 1039 1039
2017 1234 1234
2018 1835 1835
2019 1955 1955
2020 1531 1531
2021 4802 4802
2022 3909 3909
2023 4405 4405
2024 2165 2165

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 13004 13004
Dull, Blunt 3744 3744
Break 2591 2591
Naturally Worn 2190 2190
Corroded 1735 1735
Material Twisted/Bent 712 712
Device-Device Incompatibility 705 705
Adverse Event Without Identified Device or Use Problem 561 561
Material Deformation 372 372
Appropriate Term/Code Not Available 330 330
Entrapment of Device 316 316
Illegible Information 297 297
No Apparent Adverse Event 296 296
Crack 211 211
Fracture 168 168
Material Fragmentation 137 137
Material Discolored 128 128
Contamination /Decontamination Problem 105 105
Mechanical Jam 93 93
Detachment of Device or Device Component 88 88
Scratched Material 77 77
Device Operates Differently Than Expected 76 76
Device Contamination with Chemical or Other Material 51 51
Pitted 47 47
Component Missing 47 47
Loose or Intermittent Connection 46 46
Degraded 43 43
Material Integrity Problem 34 34
Device Contaminated During Manufacture or Shipping 32 32
Insufficient Information 31 31
Fitting Problem 28 28
Bent 25 25
Detachment Of Device Component 25 25
Difficult to Insert 24 24
Unintended Movement 23 23
Physical Resistance/Sticking 23 23
Connection Problem 21 21
Improper or Incorrect Procedure or Method 18 18
Material Erosion 17 17
Difficult to Remove 16 16
Disassembly 15 15
Material Separation 14 14
Product Quality Problem 13 13
Use of Device Problem 13 13
Mechanical Problem 13 13
Device Slipped 10 10
Peeled/Delaminated 9 9
Sticking 9 9
Failure To Adhere Or Bond 7 7
Device Disinfection Or Sterilization Issue 7 7
Difficult to Open or Close 6 6
Component Falling 6 6
Device Reprocessing Problem 6 6
Metal Shedding Debris 6 6
Failure to Advance 6 6
Structural Problem 5 5
Device Damaged Prior to Use 5 5
Failure to Clean Adequately 5 5
Packaging Problem 4 4
Positioning Problem 4 4
Patient-Device Incompatibility 4 4
Off-Label Use 4 4
Separation Failure 4 4
Positioning Failure 4 4
Misconnection 4 4
Complete Blockage 3 3
Loss of or Failure to Bond 3 3
Failure to Align 3 3
Tear, Rip or Hole in Device Packaging 3 3
Defective Component 3 3
Device Inoperable 3 3
Difficult to Open or Remove Packaging Material 3 3
Device Dislodged or Dislocated 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Compatibility Problem 2 2
Material Distortion 2 2
Malposition of Device 2 2
Device Or Device Fragments Location Unknown 2 2
Battery Problem 2 2
Difficult to Advance 2 2
Device Difficult to Maintain 2 2
Device Handling Problem 2 2
Noise, Audible 2 2
Material Split, Cut or Torn 2 2
Problem with Sterilization 2 2
Inadequacy of Device Shape and/or Size 2 2
Cut In Material 2 2
Suction Problem 2 2
Defective Device 2 2
Difficult To Position 2 2
Delivered as Unsterile Product 2 2
Unintended Collision 2 2
Migration or Expulsion of Device 2 2
Misassembled 1 1
Hole In Material 1 1
Unsealed Device Packaging 1 1
Particulates 1 1
Monitor failure 1 1
Difficult or Delayed Positioning 1 1
Flaked 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14831 14831
No Consequences Or Impact To Patient 5273 5273
No Information 1165 1165
No Known Impact Or Consequence To Patient 1056 1056
Insufficient Information 675 675
No Code Available 586 586
Foreign Body In Patient 374 374
No Patient Involvement 306 306
Not Applicable 218 218
Device Embedded In Tissue or Plaque 164 164
Bone Fracture(s) 85 85
Sedation 55 55
Pain 42 42
Injury 35 35
Unspecified Infection 34 34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Blood Loss 19 19
Unspecified Tissue Injury 16 16
Non-union Bone Fracture 12 12
Limb Fracture 11 11
Failure of Implant 11 11
Embolism 6 6
Septic Shock 5 5
Tissue Damage 5 5
Shock 4 4
Tachycardia 4 4
Discomfort 4 4
Loss of Range of Motion 4 4
Hemorrhage/Bleeding 4 4
Hip Fracture 4 4
Impaired Healing 3 3
Post Operative Wound Infection 3 3
Low Blood Pressure/ Hypotension 3 3
Hematoma 3 3
Fall 2 2
Debris, Bone Shedding 2 2
Laceration(s) 2 2
Nerve Damage 2 2
Swelling 2 2
Patient Problem/Medical Problem 2 2
Inadequate Osseointegration 1 1
Alteration In Body Temperature 1 1
Test Result 1 1
Skin Tears 1 1
Reaction 1 1
Deformity/ Disfigurement 1 1
Joint Disorder 1 1
Hyperextension 1 1
Swelling/ Edema 1 1
Paresthesia 1 1
Unspecified Nervous System Problem 1 1
Perforation of Vessels 1 1
Physical Entrapment 1 1
Neurological Deficit/Dysfunction 1 1
Necrosis 1 1
Respiratory Distress 1 1
Staphylococcus Aureus 1 1
Foreign Body Reaction 1 1
Wound Dehiscence 1 1
Host-Tissue Reaction 1 1
Ossification 1 1
Pulmonary Embolism 1 1
Anemia 1 1
Arthritis 1 1
Bradycardia 1 1
Burn(s) 1 1
Cyst(s) 1 1
Death 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Nov-09-2018
2 Biomet, Inc. II May-26-2016
3 Biomet, Inc. II Oct-06-2014
4 Biomet, Inc. II Dec-04-2012
5 Biomet, Inc. II Mar-04-2011
6 Cayenne Medical Inc. II Jul-25-2018
7 DePuy Mitek, Inc., a Johnson & Johnson Co. II Dec-17-2012
8 DePuy Orthopaedics, Inc. II Mar-20-2013
9 Encore Medical, Lp II Aug-31-2017
10 Extremity Medical LLC II Nov-26-2012
11 Sterilmed Inc II Jan-13-2009
12 Stryker Howmedica Osteonics Corp. II May-17-2012
13 Stryker Howmedica Osteonics Corp. II Feb-17-2010
14 Synthes (USA) Products LLC II Mar-01-2024
15 Synthes (USA) Products LLC II Dec-15-2020
16 Synthes (USA) Products LLC II Mar-05-2018
17 Synthes (USA) Products LLC II Nov-23-2016
18 Synthes (USA) Products LLC II Nov-19-2016
19 Synthes (USA) Products LLC II Jun-06-2016
20 Synthes (USA) Products LLC II Jan-05-2016
21 Synthes (USA) Products LLC II Aug-10-2015
22 Synthes USA HQ, Inc. II Aug-12-2013
23 Synthes, Inc. II Jul-16-2015
24 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Mar-20-2020
25 Trilliant Surgical Ltd. II Aug-24-2015
26 Zimmer, Inc. II Feb-06-2023
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