Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 185 185

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1647 1647
Detachment of Device or Device Component 173 173
Material Deformation 163 163
Material Separation 161 161
Material Twisted/Bent 150 150
Detachment Of Device Component 123 123
Degraded 116 116
Difficult to Open or Close 112 112
Mechanical Jam 92 92
Device Operates Differently Than Expected 66 66
Material Fragmentation 64 64
Device Contaminated During Manufacture or Shipping 58 58
Corroded 42 42
Device-Device Incompatibility 41 41
Dull, Blunt 41 41
Fracture 37 37
Adverse Event Without Identified Device or Use Problem 35 35
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
Failure to Cut 20 20
Device Dislodged or Dislocated 19 19
Retraction Problem 18 18
Crack 17 17
Bent 16 16
Use of Device Problem 15 15
Metal Shedding Debris 15 15
Defective Device 15 15
Insufficient Information 15 15
Physical Resistance/Sticking 15 15
Failure to Advance 14 14
Leak/Splash 14 14
Loose or Intermittent Connection 14 14
Material Disintegration 14 14
Entrapment of Device 13 13
Device Or Device Fragments Location Unknown 13 13
Material Integrity Problem 13 13
Material Split, Cut or Torn 12 12
Fluid/Blood Leak 12 12
Device Markings/Labelling Problem 11 11
Scratched Material 9 9
Sticking 9 9
Device Inoperable 7 7
Device Slipped 7 7
Delivered as Unsterile Product 7 7
Sharp Edges 7 7
Positioning Problem 6 6
Packaging Problem 6 6
Contamination /Decontamination Problem 6 6
Failure to Align 6 6
Device Damaged by Another Device 6 6
Misfire 6 6
Peeled/Delaminated 6 6
Unintended Collision 5 5
Improper or Incorrect Procedure or Method 5 5
Contamination 5 5
Difficult to Insert 5 5
Material Discolored 5 5
Connection Problem 5 5
Firing Problem 5 5
Illegible Information 5 5
Device Fell 4 4
Malposition of Device 4 4
Difficult to Advance 4 4
Failure to Shut Off 4 4
Failure to Cycle 4 4
Device Damaged Prior to Use 4 4
Problem with Sterilization 4 4
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
Display or Visual Feedback Problem 3 3
Deformation Due to Compressive Stress 3 3
Solder Joint Fracture 3 3
Noise, Audible 3 3
Mechanics Altered 3 3
Separation Problem 3 3
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
Tip breakage 2 2
Cut In Material 2 2
Failure to Fire 2 2
Contamination of Device Ingredient or Reagent 2 2
Material Frayed 2 2
Positioning Failure 2 2
Failure To Adhere Or Bond 2 2
Failure to Capture 2 2
Device Reprocessing Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1302 1302
No Known Impact Or Consequence To Patient 978 978
No Consequences Or Impact To Patient 407 407
Foreign Body In Patient 178 178
Device Embedded In Tissue or Plaque 97 97
Insufficient Information 95 95
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 17 17
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
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
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
Loss of Range of Motion 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
-
-