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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessories, arthroscopic
Regulation Description Arthroscope.
Product CodeNBH
Regulation Number 888.1100
Device Class 1

MDR Year MDR Reports MDR Events
2020 340 340
2021 389 389
2022 334 334
2023 491 491
2024 676 676
2025 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1010 1010
Degraded 178 178
Material Deformation 167 167
Detachment of Device or Device Component 123 123
Mechanical Jam 112 112
Material Twisted/Bent 109 109
Material Separation 87 87
Difficult to Open or Close 79 79
Device Contaminated During Manufacture or Shipping 64 64
Device-Device Incompatibility 50 50
Material Fragmentation 40 40
Fracture 38 38
Dull, Blunt 37 37
Device Damaged by Another Device 35 35
Use of Device Problem 28 28
Adverse Event Without Identified Device or Use Problem 27 27
Corroded 22 22
Flaked 22 22
Physical Resistance/Sticking 18 18
Appropriate Term/Code Not Available 17 17
Defective Device 16 16
Mechanical Problem 14 14
Contamination /Decontamination Problem 13 13
Insufficient Information 13 13
Component Missing 12 12
Leak/Splash 11 11
Crack 11 11
Material Integrity Problem 10 10
Device Markings/Labelling Problem 10 10
Material Split, Cut or Torn 10 10
Failure to Advance 9 9
Loose or Intermittent Connection 8 8
Failure to Cut 8 8
Delivered as Unsterile Product 7 7
Device Dislodged or Dislocated 7 7
Sharp Edges 7 7
Packaging Problem 6 6
Scratched Material 6 6
Firing Problem 6 6
Difficult to Remove 5 5
Connection Problem 5 5
Illegible Information 5 5
Entrapment of Device 5 5
Device Damaged Prior to Use 5 5
Material Discolored 4 4
Failure to Align 4 4
Failure to Cycle 4 4
Difficult to Advance 4 4
Device Contamination with Chemical or Other Material 4 4
Naturally Worn 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1774 1774
Insufficient Information 146 146
Foreign Body In Patient 110 110
No Known Impact Or Consequence To Patient 82 82
No Consequences Or Impact To Patient 79 79
No Information 44 44
No Patient Involvement 29 29
Device Embedded In Tissue or Plaque 17 17
Injury 12 12
No Code Available 11 11
Pain 10 10
Failure of Implant 6 6
Tissue Damage 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Not Applicable 5 5
Laceration(s) 4 4
Perforation 4 4
Unspecified Tissue Injury 4 4
Extravasation 3 3
Rupture 3 3
Swelling/ Edema 3 3
Hypersensitivity/Allergic reaction 2 2
Scar Tissue 2 2
Capsular Contracture 1 1
Itching Sensation 1 1
Nerve Damage 1 1
Neuropathy 1 1
Loss of Range of Motion 1 1
Sepsis 1 1
Burning Sensation 1 1
Numbness 1 1
Post Operative Wound Infection 1 1
Inadequate Osseointegration 1 1
Syncope/Fainting 1 1
Paresthesia 1 1
Joint Laxity 1 1
Unspecified Musculoskeletal problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Smith & Nephew, Inc. II Oct-27-2020
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