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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
2021 389 390
2022 334 335
2023 492 497
2024 676 677
2025 561 561
2026 238 238

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1270 1277
Degraded 250 250
Detachment of Device or Device Component 203 203
Material Deformation 197 199
Mechanical Jam 135 135
Material Twisted/Bent 111 111
Device Damaged by Another Device 98 98
Difficult to Open or Close 86 86
Fracture 85 86
Device-Device Incompatibility 72 72
Device Contaminated During Manufacture or Shipping 60 60
Use of Device Problem 60 60
Material Fragmentation 52 52
Physical Resistance/Sticking 32 32
Adverse Event Without Identified Device or Use Problem 23 23
Dull, Blunt 19 19
Defective Device 19 19
Leak/Splash 17 17
Flaked 17 17
Appropriate Term/Code Not Available 16 16
Component Missing 15 15
Corroded 13 13
Failure to Advance 12 12
Device Dislodged or Dislocated 11 11
Mechanical Problem 11 11
Crack 11 11
Delivered as Unsterile Product 11 11
Contamination /Decontamination Problem 11 11
Insufficient Information 10 11
Failure to Cut 9 9
Material Integrity Problem 9 9
Firing Problem 8 8
Failure to Cycle 8 8
Positioning Failure 8 9
Material Split, Cut or Torn 8 8
Sharp Edges 7 7
Material Separation 7 7
Loose or Intermittent Connection 6 6
Unstable 6 6
Display or Visual Feedback Problem 6 6
Device Markings/Labelling Problem 6 6
Device Damaged Prior to Use 6 6
Connection Problem 5 5
Unintended Movement 5 5
Packaging Problem 5 5
Contamination 4 4
Difficult to Remove 4 4
Scratched Material 4 4
Naturally Worn 4 4
Difficult to Advance 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2378 2385
Insufficient Information 185 185
Foreign Body In Patient 143 145
Device Embedded In Tissue or Plaque 15 15
Pain 11 11
Perforation 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Failure of Implant 5 5
Laceration(s) 5 5
Extravasation 4 4
Unspecified Tissue Injury 4 4
Rupture 3 3
Swelling/ Edema 3 3
Hypersensitivity/Allergic reaction 2 2
Nerve Damage 2 2
Scar Tissue 2 2
Muscle/Tendon Damage 2 2
Unspecified Infection 1 1
Neuropathy 1 1
Joint Dislocation 1 1
Sepsis 1 1
Inadequate Osseointegration 1 1
Unspecified Musculoskeletal problem 1 1
Bone Fracture(s) 1 1
Itching Sensation 1 1
Post Operative Wound Infection 1 1
Paresthesia 1 1
Burning Sensation 1 1
Loss of Range of Motion 1 1
Numbness 1 1
Capsular Contracture 1 1
Joint Laxity 1 1
Distress 1 1

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