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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device accessories, arthroscopic
Product CodeNBH
Regulation Number 888.1100
Device Class 1

MDR Year MDR Reports MDR Events
2014 79 79
2015 185 185
2016 359 359
2017 224 224
2018 307 307
2019 358 358
2020 340 340
2021 389 389
2022 334 334
2023 491 491
2024 280 280

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1692 1692
Detachment of Device or Device Component 174 174
Material Deformation 168 168
Material Separation 161 161
Material Twisted/Bent 152 152
Detachment Of Device Component 123 123
Degraded 122 122
Difficult to Open or Close 114 114
Mechanical Jam 97 97
Device Operates Differently Than Expected 66 66
Material Fragmentation 65 65
Device Contaminated During Manufacture or Shipping 58 58
Device-Device Incompatibility 43 43
Corroded 43 43
Dull, Blunt 42 42
Fracture 39 39
Adverse Event Without Identified Device or Use Problem 36 36
Component Falling 28 28
Difficult to Remove 27 27
Device Contamination with Chemical or Other Material 26 26
Flaked 25 25
Component Missing 23 23
Appropriate Term/Code Not Available 22 22
Mechanical Problem 21 21
Use of Device Problem 20 20
Physical Resistance/Sticking 20 20
Failure to Cut 20 20
Device Dislodged or Dislocated 20 20
Defective Device 18 18
Retraction Problem 18 18
Crack 17 17
Bent 16 16
Failure to Advance 16 16
Insufficient Information 15 15
Leak/Splash 15 15
Loose or Intermittent Connection 15 15
Metal Shedding Debris 15 15
Material Disintegration 14 14
Entrapment of Device 13 13
Material Integrity Problem 13 13
Device Or Device Fragments Location Unknown 13 13
Material Split, Cut or Torn 12 12
Fluid/Blood Leak 12 12
Device Markings/Labelling Problem 11 11
Scratched Material 10 10
Sticking 9 9
Device Inoperable 7 7
Device Slipped 7 7
Delivered as Unsterile Product 7 7
Sharp Edges 7 7
Device Damaged by Another Device 7 7
Failure to Align 6 6
Contamination /Decontamination Problem 6 6
Misfire 6 6
Positioning Problem 6 6
Packaging Problem 6 6
Peeled/Delaminated 6 6
Contamination 6 6
Difficult to Insert 5 5
Material Discolored 5 5
Unintended Collision 5 5
Improper or Incorrect Procedure or Method 5 5
Device Damaged Prior to Use 5 5
Firing Problem 5 5
Connection Problem 5 5
Difficult to Advance 5 5
Illegible Information 5 5
Failure to Shut Off 4 4
Malposition of Device 4 4
Device Fell 4 4
Problem with Sterilization 4 4
Failure to Cycle 4 4
Failure to Capture 3 3
Display or Visual Feedback Problem 3 3
Inadequacy of Device Shape and/or Size 3 3
Unstable 3 3
Defective Component 3 3
Fitting Problem 3 3
Overheating of Device 3 3
Nonstandard Device 3 3
Noise, Audible 3 3
Mechanics Altered 3 3
Naturally Worn 3 3
Deformation Due to Compressive Stress 3 3
Solder Joint Fracture 3 3
Separation Problem 3 3
Tip breakage 2 2
Cut In Material 2 2
Failure to Fire 2 2
Contamination of Device Ingredient or Reagent 2 2
Compatibility Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Output Problem 2 2
Unintended Movement 2 2
Component Misassembled 2 2
Incomplete or Inadequate Connection 2 2
Activation Problem 2 2
Loss of Power 2 2
Product Quality Problem 2 2
Material Rupture 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1384 1384
No Known Impact Or Consequence To Patient 978 978
No Consequences Or Impact To Patient 407 407
Foreign Body In Patient 178 178
Insufficient Information 108 108
Device Embedded In Tissue or Plaque 97 97
No Information 86 86
No Code Available 42 42
Not Applicable 37 37
No Patient Involvement 36 36
Tissue Damage 24 24
Injury 22 22
Pain 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Rupture 5 5
Failure of Implant 5 5
Laceration(s) 5 5
Unspecified Tissue Injury 4 4
Swelling/ Edema 3 3
Hypersensitivity/Allergic reaction 3 3
Burn(s) 3 3
Extravasation 3 3
Perforation 3 3
Loss of Range of Motion 2 2
Unknown (for use when the patient's condition is not known) 2 2
Needle Stick/Puncture 2 2
Bone Fracture(s) 2 2
Scar Tissue 2 2
Patient Problem/Medical Problem 2 2
Inadequate Osseointegration 1 1
Paresthesia 1 1
Unspecified Musculoskeletal problem 1 1
Nerve Damage 1 1
Neuropathy 1 1
Unspecified Infection 1 1
Inflammation 1 1
Itching Sensation 1 1
Fever 1 1
Foreign Body Sensation in Eye 1 1
Arthritis 1 1
Exposure to Body Fluids 1 1
Capsular Contracture 1 1
Purulent Discharge 1 1
Edema 1 1
Burn, Thermal 1 1
Numbness 1 1
Post Operative Wound Infection 1 1
Distress 1 1
Complaint, Ill-Defined 1 1
Toxicity 1 1
Burning Sensation 1 1
Staphylococcus Aureus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioPro, Inc. II Aug-12-2019
2 Ceterix Orthopedics, Inc. II Aug-28-2018
3 Ceterix Orthopedics, Inc. II Nov-09-2015
4 DePuy Mitek, Inc., a Johnson & Johnson Co. II May-09-2013
5 Instratek, Incorporated II Mar-08-2013
6 Integra LifeSciences Corp. II Mar-19-2012
7 Smith & Nephew, Inc. II Oct-27-2020
8 Smith & Nephew, Inc. II Jul-18-2016
9 Smith & Nephew, Inc. II Feb-10-2016
10 Smith & Nephew, Inc. Endoscopy Division II Oct-12-2010
11 Smith & Nephew, Inc. Endoscopy Division II Jul-14-2009
12 Smith & Nephew, Inc., Endoscopy Div. II Feb-18-2016
13 Smith & Nephew, Inc., Endoscopy Div. II Jan-29-2016
14 Smith & Nephew, Inc., Endoscopy Div. II Nov-24-2009
15 Stryker Corporation II Jun-03-2016
16 Surgical Instrument Service And Savings, Inc. II Jul-01-2013
17 TAG Medical Corp. II Jan-19-2010
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