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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
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 875 875
Material Separation 152 152
Material Deformation 140 140
Material Twisted/Bent 121 121
Degraded 109 109
Detachment of Device or Device Component 102 102
Difficult to Open or Close 100 100
Mechanical Jam 84 84
Device Contaminated During Manufacture or Shipping 53 53
Device-Device Incompatibility 40 40
Dull, Blunt 38 38
Material Fragmentation 33 33
Adverse Event Without Identified Device or Use Problem 28 28
Fracture 25 25
Flaked 22 22
Device Contamination with Chemical or Other Material 21 21
Failure to Cut 16 16
Corroded 16 16
Mechanical Problem 15 15
Component Missing 15 15
Appropriate Term/Code Not Available 15 15
Crack 14 14
Insufficient Information 13 13
Physical Resistance/Sticking 11 11
Defective Device 11 11
Use of Device Problem 10 10
Device Markings/Labelling Problem 10 10
Fluid/Blood Leak 10 10
Leak/Splash 10 10
Material Split, Cut or Torn 9 9
Material Integrity Problem 8 8
Device Dislodged or Dislocated 8 8
Delivered as Unsterile Product 7 7
Difficult to Remove 7 7
Entrapment of Device 7 7
Sharp Edges 7 7
Packaging Problem 6 6
Contamination /Decontamination Problem 6 6
Failure to Advance 5 5
Material Discolored 5 5
Firing Problem 5 5
Illegible Information 5 5
Scratched Material 4 4
Failure to Cycle 4 4
Problem with Sterilization 4 4
Loose or Intermittent Connection 4 4
Connection Problem 4 4
Failure to Align 4 4
Device Damaged Prior to Use 3 3
Solder Joint Fracture 3 3
Device Damaged by Another Device 3 3
Difficult to Advance 3 3
Unstable 3 3
Contamination 3 3
Device Fell 3 3
Activation Problem 2 2
Separation Problem 2 2
Unintended Movement 2 2
Noise, Audible 2 2
Component Misassembled 2 2
Positioning Problem 2 2
Output Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Slipped 2 2
Nonstandard Device 2 2
Overheating of Device 2 2
Misfire 2 2
Contamination of Device Ingredient or Reagent 2 2
Product Quality Problem 2 2
Obstruction of Flow 1 1
Malposition of Device 1 1
Deformation Due to Compressive Stress 1 1
Capturing Problem 1 1
Residue After Decontamination 1 1
Tear, Rip or Hole in Device Packaging 1 1
Defective Component 1 1
Improper or Incorrect Procedure or Method 1 1
Activation, Positioning or Separation Problem 1 1
Infusion or Flow Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Peeled/Delaminated 1 1
Loss of Power 1 1
Migration or Expulsion of Device 1 1
Misassembled 1 1
Retraction Problem 1 1
Material Rupture 1 1
Positioning Failure 1 1
Difficult to Fold, Unfold or Collapse 1 1
Material Frayed 1 1
Difficult to Insert 1 1
Device Reprocessing Problem 1 1
Complete Blockage 1 1
Disconnection 1 1
Material Disintegration 1 1
No Display/Image 1 1
Display or Visual Feedback Problem 1 1
Ejection Problem 1 1
No Apparent Adverse Event 1 1
Therapeutic or Diagnostic Output Failure 1 1
Difficult or Delayed Separation 1 1

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 226 226
No Consequences Or Impact To Patient 218 218
Foreign Body In Patient 119 119
Insufficient Information 91 91
No Information 47 47
Not Applicable 32 32
No Patient Involvement 32 32
Device Embedded In Tissue or Plaque 30 30
No Code Available 17 17
Pain 13 13
Injury 13 13
Tissue Damage 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Failure of Implant 5 5
Laceration(s) 5 5
Unspecified Tissue Injury 4 4
Swelling/ Edema 3 3
Rupture 3 3
Extravasation 3 3
Perforation 3 3
Hypersensitivity/Allergic reaction 2 2
Exposure to Body Fluids 1 1
Capsular Contracture 1 1
Nerve Damage 1 1
Neuropathy 1 1
Itching Sensation 1 1
Burning Sensation 1 1
Numbness 1 1
Post Operative Wound Infection 1 1
Needle Stick/Puncture 1 1
Inadequate Osseointegration 1 1
Patient Problem/Medical Problem 1 1
Paresthesia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioPro, Inc. II Aug-12-2019
2 Smith & Nephew, Inc. II Oct-27-2020
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