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 129 129

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1622 1622
Detachment of Device or Device Component 168 168
Material Separation 161 161
Material Deformation 156 156
Material Twisted/Bent 148 148
Detachment Of Device Component 123 123
Degraded 110 110
Difficult to Open or Close 109 109
Mechanical Jam 91 91
Device Operates Differently Than Expected 66 66
Material Fragmentation 64 64
Device Contaminated During Manufacture or Shipping 53 53
Corroded 42 42
Dull, Blunt 41 41
Device-Device Incompatibility 40 40
Adverse Event Without Identified Device or Use Problem 35 35
Fracture 33 33
Component Falling 28 28
Difficult to Remove 27 27
Device Contamination with Chemical or Other Material 26 26
Flaked 25 25
Component Missing 22 22
Mechanical Problem 21 21
Failure to Cut 20 20
Device Dislodged or Dislocated 19 19
Retraction Problem 18 18
Crack 17 17
Appropriate Term/Code Not Available 17 17
Bent 16 16
Metal Shedding Debris 15 15
Insufficient Information 15 15
Physical Resistance/Sticking 14 14
Use of Device Problem 14 14
Leak/Splash 14 14
Material Disintegration 14 14
Entrapment of Device 13 13
Loose or Intermittent Connection 13 13
Material Integrity Problem 13 13
Defective Device 13 13
Device Or Device Fragments Location Unknown 13 13
Failure to Advance 13 13
Fluid/Blood Leak 12 12
Device Markings/Labelling Problem 11 11
Material Split, Cut or Torn 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
Packaging Problem 6 6
Positioning Problem 6 6
Contamination /Decontamination Problem 6 6
Device Damaged by Another Device 6 6
Failure to Align 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
Failure to Shut Off 4 4
Malposition of Device 4 4
Difficult to Advance 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
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
Mechanics Altered 3 3
Noise, Audible 3 3
Separation Problem 3 3
Incomplete or Inadequate Connection 2 2
Activation Problem 2 2
Component Misassembled 2 2
Output Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Unintended Movement 2 2
Cut In Material 2 2
Failure to Fire 2 2
Contamination of Device Ingredient or Reagent 2 2
Compatibility Problem 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
Loss of Power 2 2
Product Quality Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1253 1253
No Known Impact Or Consequence To Patient 978 978
No Consequences Or Impact To Patient 407 407
Foreign Body In Patient 177 177
Device Embedded In Tissue or Plaque 97 97
Insufficient Information 91 91
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
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
-
-