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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device passer
Regulation Description Orthopedic manual surgical instrument.
Product CodeHWQ
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2020 171 171
2021 160 160
2022 63 63
2023 60 60
2024 50 50
2025 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Break 316 316
Material Separation 42 42
Detachment of Device or Device Component 37 37
Mechanical Jam 25 25
Mechanical Problem 16 16
Material Deformation 12 12
Adverse Event Without Identified Device or Use Problem 12 12
Physical Resistance/Sticking 12 12
Fracture 10 10
Material Fragmentation 9 9
Material Integrity Problem 7 7
Insufficient Information 7 7
Firing Problem 6 6
Misassembled 5 5
Material Split, Cut or Torn 5 5
Device Dislodged or Dislocated 4 4
Difficult to Open or Close 4 4
No Apparent Adverse Event 4 4
Ejection Problem 4 4
Device Damaged Prior to Use 3 3
Nonstandard Device 3 3
Device-Device Incompatibility 3 3
Device Fell 3 3
Failure to Fire 3 3
Failure to Cycle 3 3
Difficult to Open or Remove Packaging Material 2 2
Activation Problem 2 2
Separation Problem 2 2
Failure to Advance 2 2
Entrapment of Device 2 2
Flaked 2 2
Solder Joint Fracture 1 1
Use of Device Problem 1 1
Unstable 1 1
Problem with Sterilization 1 1
Defective Device 1 1
Expiration Date Error 1 1
Difficult to Fold, Unfold or Collapse 1 1
Positioning Failure 1 1
Crack 1 1
Failure to Capture 1 1
Inaccurate Information 1 1
Migration 1 1
Appropriate Term/Code Not Available 1 1
Unintended Movement 1 1
Material Twisted/Bent 1 1
Device Contaminated During Manufacture or Shipping 1 1
Difficult to Remove 1 1
Unsealed Device Packaging 1 1
Delivered as Unsterile Product 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 373 373
No Known Impact Or Consequence To Patient 91 91
No Consequences Or Impact To Patient 27 27
Foreign Body In Patient 18 18
No Information 12 12
Insufficient Information 7 7
No Patient Involvement 6 6
Injury 5 5
Device Embedded In Tissue or Plaque 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Cardiac Arrest 2 2
Hemorrhage/Bleeding 2 2
Hypersensitivity/Allergic reaction 2 2
Perforation 1 1
Loss of Range of Motion 1 1
Chills 1 1
Rupture 1 1
Failure of Implant 1 1
Unspecified Infection 1 1

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