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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device passer, wire, orthopedic
Regulation Description Orthopedic manual surgical instrument.
Product CodeHXI
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 5 5
2021 2 2
2022 8 8
2023 12 17
2024 6 6
2025 3 3
2026 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 21 21
Break 13 13
Detachment of Device or Device Component 5 5
Contamination /Decontamination Problem 4 4
Packaging Problem 3 3
Patient Device Interaction Problem 2 2
Insufficient Device Problem Information 2 2
Material Too Soft/Flexible 2 2
Mechanical Problem 1 1
Unsealed Device Packaging 1 1
Defective Device 1 1
Material Fragmentation 1 1
Material Separation 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 27 27
Foreign Body In Patient 26 26
Insufficient Information 4 4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 4 4
Blister 3 8
Rash 3 8
Rheumatoid Arthritis 1 6
Hypersensitivity/Allergic reaction 1 6
Inflammation 1 6
No Known Impact Or Consequence To Patient 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Paragon 28, Inc. II Jul-17-2026
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