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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 171 172
2021 160 160
2022 63 65
2023 60 60
2024 50 50
2025 63 63

Device Problems MDRs with this Device Problem Events in those MDRs
Break 335 337
Detachment of Device or Device Component 49 49
Material Separation 42 42
Mechanical Jam 26 26
Mechanical Problem 17 17
Material Fragmentation 14 14
Material Deformation 13 13
Physical Resistance/Sticking 12 12
Fracture 12 12
Adverse Event Without Identified Device or Use Problem 12 12
Difficult to Open or Close 7 7
Insufficient Information 7 8
Material Integrity Problem 7 7
Firing Problem 6 6
Material Split, Cut or Torn 5 5
Misassembled 5 5
Failure to Cycle 4 4
Device Dislodged or Dislocated 4 4
No Apparent Adverse Event 4 5
Ejection Problem 4 4
Device-Device Incompatibility 3 3
Flaked 3 3
Nonstandard Device 3 3
Device Damaged Prior to Use 3 3
Device Fell 3 3
Failure to Fire 3 3
Failure to Advance 2 2
Activation Problem 2 2
Entrapment of Device 2 2
Difficult to Open or Remove Packaging Material 2 2
Unstable 2 2
Separation Problem 2 2
Material Twisted/Bent 1 1
Use of Device Problem 1 1
Problem with Sterilization 1 1
Positioning Failure 1 1
Difficult to Insert 1 1
Solder Joint Fracture 1 1
Delivered as Unsterile Product 1 1
Difficult to Remove 1 1
Defective Device 1 1
Unsealed Device Packaging 1 1
Expiration Date Error 1 1
Migration 1 1
Failure to Capture 1 1
Retraction Problem 1 1
Unintended Movement 1 1
Difficult to Fold, Unfold or Collapse 1 1
Crack 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 409 412
No Known Impact Or Consequence To Patient 91 92
No Consequences Or Impact To Patient 27 27
Foreign Body In Patient 19 19
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
Hypersensitivity/Allergic reaction 2 2
Cardiac Arrest 2 2
Hemorrhage/Bleeding 2 2
Unspecified Infection 1 1
Failure of Implant 1 1
Perforation 1 1
Rupture 1 1
Chills 1 1
Loss of Range of Motion 1 1
Laceration(s) 1 1

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